Product Code: BYD FDA class 1 21 CFR 868.5375

Condenser, Heat And Moisture (Artificial Nose)

Anesthesiology

The Condenser, Heat and Moisture (Artificial Nose) is a passive device placed in the breathing circuit between the patient's airway and the ventilator or anesthesia system that captures heat and moisture from exhaled gas and returns it to the inhaled gas, reducing airway drying. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BYD, regulated under 21 CFR 868.5375 in the Anesthesiology specialty.

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510(k)s

FEI Numbers

125

Registration Numbers

125

Unique Applicants

Years Active

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Basic Information

Product Code: BYD
Device Class: FDA class 1
Regulation Number: 868.5375
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 73 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K955008	HEAT & MOISTURE EXCHANGER	Jan 30, 1996	Substantially Equivalent	Intertech Resources, Inc.
K954194	DISPOSABLE HME/FILTER	Oct 20, 1995	Substantially Equivalent	Engstrom Medical
K953580	HEAT MOISTURE EXCHANGER	Sep 15, 1995	Substantially Equivalent	Intertech Resources, Inc.
K953507	TYPE 1 & 2 (HUMIDAIR I & II)	Sep 07, 1995	Substantially Equivalent	Icor AB
K953620	WARM N WET HMEF W/LUER ADAPTER	Aug 25, 1995	Substantially Equivalent	Hospitak, Inc.
K953619	WARM N WET HME W/LUER ADAPTER	Aug 25, 1995	Substantially Equivalent	Hospitak, Inc.
K953544	HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT	Aug 25, 1995	Substantially Equivalent	Gibeck, Inc.
K953540	EEE	Aug 25, 1995	Substantially Equivalent	Edentec Corp.
K953491	HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE	Aug 25, 1995	Substantially Equivalent	Gibeck, Inc.
K952845	HUMID-VENT TRACH-VENT	Jul 25, 1995	Substantially Equivalent	Gibeck, Inc.
K952844	HUMID-VENT 2	Jul 20, 1995	Substantially Equivalent	Gibeck, Inc.
K952750	HUMID-VENT 1	Jul 20, 1995	Substantially Equivalent	Gibeck, Inc.
K952823	FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE	Jul 13, 1995	Substantially Equivalent	Icor AB
K952084	HUMID-VENT FILTER PEDI	Jun 12, 1995	Substantially Equivalent	Gibeck, Inc.
K952036	FLEXLIFE	Jun 08, 1995	Substantially Equivalent	Mallinckrodt Medical
K946209	DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME	Jun 08, 1995	Substantially Equivalent	Med-Plastics Intl., Inc.
K951856	HUMID-VENT MICRO	Jun 07, 1995	Substantially Equivalent	Gibeck, Inc.
K950447	FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT	Feb 21, 1995	Substantially Equivalent	Vital Signs, Inc.
K945359	AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H	Feb 21, 1995	Substantially Equivalent	Artema Medical AB
K945657	DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER	Dec 07, 1994	Substantially Equivalent	Tec II Medical, Inc.
K943915	HEAT AND MOISTURE EXCHANGER FILTER (HME)	Oct 14, 1994	Substantially Equivalent	Medicomp, Inc.
K944194	DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME	Sep 13, 1994	Substantially Equivalent	Med-Tek Innovations, Inc.
K942794	HYGROLIFE	Aug 22, 1994	Substantially Equivalent	Mallinckrodt Medical
K941987	HEAT AND MOISTURE EXCHANGERS AND FILTERS	Aug 15, 1994	Substantially Equivalent	Icor AB
K941436	AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF	Jun 08, 1994	Substantially Equivalent	Icor AB
K941813	VENSHIELD	May 03, 1994	Substantially Equivalent	Cybermedic, Inc.
K941585	HYGROSTER	Apr 19, 1994	Substantially Equivalent	Mallinckrodt Medical
K941535	TRACHEOLIFE	Apr 15, 1994	Substantially Equivalent	Mallinckrodt Medical
K935036	HEPA FILTERED HEAT AND MOISTURE EXCHANGER	Jan 25, 1994	Unknown	Intertech Resources, Inc.
K934441	KING SYSTEMS HME	Dec 02, 1993	Substantially Equivalent	King Systems Corp.
K934190	HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION	Nov 24, 1993	Substantially Equivalent	Bird Life Design
K933597	AQUA+TFILTERHME/THME/AQUA+TFILTERHCH/THCH	Nov 01, 1993	Substantially Equivalent	Arthro-Medic, Inc.
K925622	FHB, FHB-T, FHBFLEX, FHBFLEX-T	May 26, 1993	Substantially Equivalent	Icor AB
K922946	VAPORTEMP HEAT AND MOISTURE EXCHANGER	Mar 08, 1993	Substantially Equivalent	Mallinckrodt Medical
K923865	5701, 5702, 5704, 5706 HYGROSCOPIC CONDENSER HUMID	Feb 01, 1993	Substantially Equivalent	Vital Signs, Inc.
K923910	HEAT MOISTURE CONDENSER	Jan 26, 1993	Substantially Equivalent	Concord/Portex
K915786	BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID.	Jun 30, 1992	Substantially Equivalent	Helix Medical, Inc.
K914336	BREATHE EASY	Mar 25, 1992	Substantially Equivalent	Vital Signs, Inc.
K912700	FLOCARE DRY CAS SAMPLING PORT MODELS	Sep 11, 1991	Substantially Equivalent	Flocare Medical
K912699	FLOCARE LF-A	Sep 11, 1991	Substantially Equivalent	Flocare Medical
K912336	ARTEMA AQUA+ FLEX	Jul 26, 1991	Substantially Equivalent	Artema Medical AB
K912335	ARTEMA AQUA+ N	Jul 26, 1991	Substantially Equivalent	Artema Medical AB
K912334	ARTEMA AQUA+ T & TS	Jul 26, 1991	Substantially Equivalent	Artema Medical AB
K912333	ARTEMA AQUA+	Jul 26, 1991	Substantially Equivalent	Artema Medical AB
K903519	INTERTECH(TM) HEAT AND MOISTURE EXCHANGER	Dec 13, 1990	Substantially Equivalent	Intertech Resources, Inc.
K904338	ICOR HCH 4, ICOR HCH 7	Dec 04, 1990	Substantially Equivalent	Icor AB
K904193	FLOCARE	Nov 29, 1990	Substantially Equivalent	Flocare Medical
K903057	FREEVENT (TM)	Nov 20, 1990	Substantially Equivalent	Pharma Systems, Inc.
K903058	BACT-HME (TM)	Nov 09, 1990	Substantially Equivalent	Pharma Systems, Inc.
K903054	HME-10 (TM)	Oct 31, 1990	Substantially Equivalent	Pharma Systems, Inc.
K902501	FLOCARE N	Jul 02, 1990	Substantially Equivalent	Flocare Medical
K900150	HCH 9165, 9165 S, 9166, HFH, HFH-T HEAT MOISTURE	Jan 25, 1990	Substantially Equivalent	Icor AB
K885313	HUMIDI-FLEX TM	Oct 11, 1989	Substantially Equivalent	Life Design Systems, Inc.
K893875	FLOCARE	Aug 11, 1989	Substantially Equivalent	Mega-Tech Intl., Inc.
K881657	HUMID-VENT FILTER	Jun 24, 1988	Substantially Equivalent	Gibeck Respiration
K881656	HUMID-VENT 2 S FLEX	Jun 16, 1988	Substantially Equivalent	Gibeck Respiration
K881644	HUMID-VENT 2 S	Jun 10, 1988	Substantially Equivalent	Gibeck Respiration
K881308	BREATH-EASY	May 17, 1988	Substantially Equivalent	Icor AB
K874597	THERMOVENT 600, 1200, T, 02	Jan 19, 1988	Substantially Equivalent	Portex, Inc.
K873768	HUMID-VENT(R) 2 PORT	Nov 24, 1987	Substantially Equivalent	Gibeck Respiration
K873767	HUMID-VENT(R) MINI	Nov 06, 1987	Substantially Equivalent	Gibeck Respiration
K872371	ICOR NEONATAL HCH	Sep 04, 1987	Substantially Equivalent	Icor AB
K872153	STOM-VENT	Aug 03, 1987	Substantially Equivalent	Gibeck Respiration
K864095	ENGSTROM EDITH MODELS 500,1000,1500 & 1500F	Feb 20, 1987	Substantially Equivalent	Gambro, Inc.
K862020	HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER	Jun 30, 1986	Substantially Equivalent	Intertech/Ohio
K854012	AMERICAN PHARMASEAL HUMIDAIR CONDENSER	Dec 03, 1985	Substantially Equivalent	American Pharmaseal Div. Ahsc
K852601	SERVO HUMIDIFIER 153	Jul 08, 1985	Substantially Equivalent	Siemens Elema AB
K844040	SERVO HUMIDIFIER 152 SIEMENS-ELEMA AB	Oct 25, 1984	Substantially Equivalent	Siemens Elema AB
K834292	PALL HEAT MOISTURE EXCHANGING FILTER	Apr 04, 1984	Substantially Equivalent	Pall Biomedical Products Co.
K840399	FOAM NOSE	Mar 16, 1984	Substantially Equivalent	Mallinckrodt Critical Care
K840398	INLINE FOAM NOSE	Mar 16, 1984	Substantially Equivalent	Mallinckrodt Critical Care
K821365	ENGSTOM EDITH	Jun 29, 1982	Substantially Equivalent	Lkb Instruments, Inc.
K790681	SIEMENS-ELEMA A.B. SERVO HUMIDIFIER 150	Apr 13, 1979	Substantially Equivalent	Siemens Corp.