Product Code: HEB FDA class 2 21 CFR 884.5470

Tampon, Menstrual, Unscented

Obstetrics/Gynecology

The Unscented Menstrual Tampon is an absorbent intravaginal device designed to collect menstrual fluid during menstruation. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification prior to marketing. The product code is HEB, regulated under 21 CFR 884.5470, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

510(k)s
189
FEI Numbers
92
Registration Numbers
93
Unique Applicants
61
Years Active
48

Basic Information

Product Code
HEB
Device Class
FDA class 2
Regulation Number
884.5470
Medical Specialty
Obstetrics/Gynecology
Review Panel
OB
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

Definition

An unscented menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge.

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 189 510(k) clearances via K numbers.

K Number Device Name
K252005 Livi Device
K253719 Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons
K252939 COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS
K252613 Unscented menstrual three-piece applicator tampon
K251033 Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons
K242105 SABA Tampons
K241064 Unscented Tampon
K240708 Organic Cotton Tampon; Organic Cotton PESCVcord Tampon
K232060 TOSAMA Reusable Applicator
K232598 Unscented Menstrual Tampon
K223883 Daye Tampon
K231341 Organic cotton tampon, Viscose tampon
K230419 Sequel Tampon with Plastic Applicator
K223749 U by Kotex® Click® Unscented Menstrual Tampons
K222046 Unscented Menstrual Tampon
K212277 Tempo Tampon
K220238 Cohitech Cottonlock Tampons with Reusable Applicator
K211775 Cohitech Organic Cotton Non-Applicator Cottonlock Tampons
K212479 Cohitech Reusable Tampon Applicator
K212272 Tempo Natural Tampon
K212304 Callaly Tampliner (super plus absorbency)
K211519 Every Cycle Reusable Tampon Applicator
K211469 Callaly Tampliner
K201003 Callaly Tampliner
K192557 Youjia Unscented Tampon with Plastic Applicators
K191666 Unscented W long plastic and cardboard applicator tampons
K191431 Interlude Rolled Tampons in Plastic Applicator
K182142 FEMME Applicator Tampon
K182817 CottonDay Tampon
K182814 Rael Tampon
K190218 Unscented Menstrual Tampon
K182813 COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT
K181911 Interlude 100% Cotton Tampon
K180850 re.t.a Reuseable Tampon Applicator
K173225 Interlude and private label Unscented 3-piece compact applicator tampon
K180167 Playtex Stella Tampons
K172504 Tosama Biobased Applicator Tube Menstrual Tampon
K172118 U by Kotex Click Unscented Menstrual Tampons
K162746 Ontex and other proprietary names
K161877 Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl
K152284 COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS
K151470 Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency
K151170 Tosama 100% Organic Cotton Menstrual Tampon
K142786 Ontex Unscented Tampons with Colored Plastic Applicators
K150897 Tosama 100% Cotton Menstrual Tampon
K140077 ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED
K141294 U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS
K132595 ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS
K133244 TAMPAX M PLASTIC TAMPONS, UNSCENTED
K131543 TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED
K130609 VEEDA 100% COTTON MENSTRUAL TAMPON
K122603 ONTEX AND OTHER PROPRIETARY NAMES
K120481 LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,
K113699 TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED
K113036 U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS
K112635 U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
K110669 TAMPAX C PLASTIC TAMPONS, UNSCENTED
K103311 U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS
K102445 ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS
K091281 TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA
K091749 U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS
K090819 ONTEX TAMPON (UNSCENTED)
K092054 MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON
K090071 ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS
K091084 MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS
K080733 COTTONS 100% NATURAL COTTON TAMPONS
K090098 MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON
K080775 MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS
K062001 ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
K062638 TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS
K061486 TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES)
K051290 TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED)
K050660 FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
K040999 TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES)
K030474 PH BUFFERING PLASTIC APPLICATOR TAMPON
K032636 PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)
K031067 FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS
K023789 O.B. TAMPONS
K023479 FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES
K020535 INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
K992493 VIPON TAMPON
K002096 TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TAMPONS, OPEN END FLUSHABLE APPLICATOR
K001641 TAMPONS
K993794 PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS
K990536 O.B. TAMPON
K991118 O.B. APPLICATOR TAMPONS, O.B. TAMPONS
K983478 ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON
K983381 VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS
K981953 VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS
K981760 PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598
K980478 PLAYTEX TAMPONS #03498
K974629 O.B. APPLICATOR AND NON-APPLICATOR TAMPONS
K970954 O.B. APPLICATOR TAMPONS
K971174 PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS
K971228 FEMTEX 100% COTTON TAMPONS
K970108 HARMONIES MENSTRUAL TAMPON
K970232 FEMTEX 100% COTTON DENTLE TOUCH TAMPONS
K965064 ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON
K963034 FEMTEX GENTLE TOUCH TAMPONS
K963032 FREE CHOICE
K962712 YSANPOINT) (MENSTRUAL) DIGITAL TAMPON
K962476 UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR
K961926 SANPOINT MENSTRUAL TAMPON
K960341 TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS
K954445 NON APPLICATOR TAMPON, UNTREATED
K954942 NATRACAREN APPLICATOR TAMPON
K953333 MENSTRUAL TAMPON
K950194 TAMPON, UNTREATED
K952394 PLAYTEX TAMPONS #13695
K951924 ORGANIC TAMPONS
K944155 PLAYTEX ULTIMATES SILK GLIDE TAMPONS #23094
K944154 PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22994
K944064 PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22894
K944834 UNSCENTED MENSTRUAL TAMPONS
K941936 UNSCENTED MENSTRUAL TAMPON
K942418 PLAYTEX TAMPONS MODEL 13794
K941863 O.B. TAMPON
K930400 TERRA FEMME
K930149 KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+
K914430 NATRACARE TAMPON
K920238 PRIVATE LABELS AND FEMTEX
K924303 TAMPAX TAMPON, REGULAR ABSORBENCY
K923932 TAMPAX TAMPONS, SUPER ABSORBENCY
K923985 UNSCENTED MENSTRUAL TAMPON
K912941 TAMPON, UNTREATED
K912552 UNSCENTED MENSTRUAL TAMPON W/A MODIFIED APPLICATOR
K904937 PLAYTEX ULTIMATES UNSCENTED AND SCENTED TAMPONS
K897007 UNSCENTED MENSTRUAL TAMPON
K897008 MENSTRUAL TAMPON
K896994 KOTEX SECURITY TAMPONS (SEVERAL TYPE)
K896989 TAMPAX TAMPON
K896114 TAMPON, PETAL SOFT PLASTIC APPLI., SUPER ABSORB.
K896113 TAMPON, PETAL SOFT PLASTIC APPLICATOR, SUPER PLUS
K896112 TAMPAX TAMPON, FLUSHABLE APPLICATOR, SUPER PLUS
K894846 UNSCENTED MENSTRUAL TAMPON
K893725 PLAYTEX TAMPONS, NON-DEODORANT/DEODORANT
K885194 KOTEX SECURITY TUBE TAMPONS
K881384 INTERLABIAL PAD
K884305 KOTEX STICK TAMPONS, REGULAR AND SUPER
K883867 CERVICAL BIOPSY INSTRUMENT
K871715 ADVERTISING AND LABEL CHANGE ON TAMBRANDS TAMPONS
K872018 KOTEX STICK TAMPONS, REGULAR AND SUPER
K871642 TAMPAX TAMPON, REGULAR
K870539 O.B. SLENDER REGULAR TAMPON
K864859 SUPER PETAL SOFT PLASTIC APPLICATOR TAMPAX TAMPONS
K864652 SUPER PLUS TAMPONS
K864651 SUPER TAMPONS
K864650 SLENDER REGULAR TAMPONS
K864649 REGULAR PETAL SOFT PLASTIC APPLICATOR TAMPONS
K864648 SUPER PLUS PETAL SOFT PLASTIC APPLICATOR TAMPONS
K870361 TAMPAX CLOSED-END FLUSHABLE TAMPON, SLENDER REGU.
K870360 TAMPAX CLOSED-END FLUSHABLE TAMPON, SUPER PLUS
K870359 TAMPAX CLOSED-END FLUSHABLE TAMPON, ORIG. REGULAR
K870358 TAMPAX CLOSED-END FLUSHABLE TAMPON, SUPER
K864750 KOTEX SECURITY TAMPONS, REGULAR AND SUPER
K863464 TAMPAX SUPER TAMPONS
K861913 SLENDER REGULAR TAMPAX TAMPONS
K861912 SUPER PLUS TAMPAX TAMPONS
K861911 SUPER PLUS PETAL SOFT PLASTIC APPLI. TAMPAX TAMPON
K861910 SUPER PETAL SOFT PLASTIC APPLICATOR TAMPAX TAMPONS
K861909 REGULAR PETAL SOFT PLASTIC APPLI. TAMPAX TAMPONS
K861908 TAMPAX ORIGINAL REGULAR TAMPON
K861907 TAMPAX SUPER TAMPONS
K861906 TAMPAX JUNIOR TAMPONS
K853192 KOTEX SECURITY TUBE TAMPON
K851941 UNSCENTED MENSTRUAL TAMPONS
K852063 PLAYTEX SLENDER REG. TAMPONS & DEODORANT TAMPONS
K851356 PLAYTEX SUPER TAMPONS & SUPER DEODORANT TAMPONS
K851355 PLAYTEX SUPER PLUS TAMPONS & DEODORANT TAMPONS
K844936 SUPER TAMPAX TAMPONS
K844935 ORIGINAL REGULAR TAMPAX TAMPONS
K842619 REGULAR PETAL SOFT PLASTIC APPLICATOR
K842618 SUPER PETAL SOFT PLASTIC APPLICATOR TAMP
K832818 UNSCENTED MENSTRUAL TAMPON
K833179 O.B. TAMPONS
K820174 TAMPAX TAMPONS
K813642 PETAL SOFT PLASTIC APPLICATOR TAMPAX
K812870 IMPROVED PLAYTEX TAMPON
K811388 PLAYTEX COTTON DIGITAL TAMPON
K811385 PLAYTEX DIGITAL TAMPON
K811992 ASSURE NATURAL FIT TAMPON
K811983 JOHNSON & JOHNSON O.B. TAMPONS
K802760 PETAL SOFT PLASTIC APPLICATOR TAMPAX
K802193 KOTEX SECURITY TUBE TAMPONS
K800777 TAMPAX TAMPONS
K791274 RELY TAMPON
K790385 KOTEX TUBE AND STICK TAMPON
K780648 MODIFIED UNTREATED TAMPAX TAMPONS
K780243 TAMPON, RELY MODIFIED

FEI Numbers

This FDA classification entry is associated with 92 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 93 registration numbers. Click on an entry to view related FDA registrations.