Product Code: LRS FDA class 2 21 CFR 880.5200

I.V. Start Kit

General Hospital

The IV Start Kit is a prepackaged, sterile convenience kit containing the supplies needed to establish intravenous access, such as needles, catheters, antiseptic swabs, and securing materials, assembled in accordance with the May 20, 1997 FDA guidance on convenience kits interim regulatory guidance. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification. The product code is LRS, regulated under 21 CFR 880.5200, within the General Hospital medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

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Years Active

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Basic Information

Product Code: LRS
Device Class: FDA class 2
Regulation Number: 880.5200
Medical Specialty: General Hospital
Review Panel: SU
Submission Type: 7

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 30 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K050654	AMSINO I.V. START KIT	May 02, 2005	Substantially Equivalent	Amsino International, Inc.
K001879	INFUSION IV SET	Nov 20, 2001	Substantially Equivalent	Nirvi Intl. USA
K963722	IV START KIT	Nov 27, 1996	Substantially Equivalent	Grand Medical Products
K951167	EMS I.V. START KIT	May 16, 1995	Substantially Equivalent for Some Indications	Emergency Medical Supply, Inc.
K950184	B. BRAUN IV START KITS	Mar 15, 1995	Unknown	B. Braun of America, Inc.
K944041	PERSONAL HEARING SYSTEM	Dec 27, 1994	Substantially Equivalent	Resound Corp.
K943941	SAFESTART VASCULAR ACCESS START KIT	Oct 20, 1994	Substantially Equivalent	Becton Dickinson Vascular Access, Inc.
K935684	IV START KIT	Jun 10, 1994	Unknown	Cush Medical Products
K942238	I.V. STARTPAK VASCULAR ACCESS START KIT	Jun 03, 1994	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K941469	IV START KIT	May 12, 1994	Substantially Equivalent	Clinical Resources, Inc.
K925018	IV PREP KIT W/O DRESSING (NON-STERILE)	Aug 27, 1993	Unknown	Customed, Inc.
K925017	IV PREP KIT (NON-STERILE)	Aug 27, 1993	Substantially Equivalent	Customed, Inc.
K933041	COLD CD ASP MODULE, ITE	Aug 02, 1993	Substantially Equivalent	Electone, Inc.
K930196	CEPTI-SEAL I.V. PREP KIT	Jul 02, 1993	Unknown	Medi-Flex Hospital Products, Inc.
K924538	IV START KIT	Jul 02, 1993	Unknown	Cml, Inc.
K923361	I.V. START KIT, STERILE, DISPOSABLE	Jun 28, 1993	Unknown	Trinity Laboratories, Inc.
K924811	I.V. START KIT	Jun 17, 1993	Unknown	Transidyne General Corp.
K926031	PRO-PREP I.V. START/SCRUB-PREP/BLOOD CULTURE KIT	Jun 07, 1993	Unknown	Brigam Medical, Inc.
K922533	IV START KIT CUSTOM SMP # A-Z	Mar 23, 1993	Unknown	Specialty Medical Products Co.
K914475	IV START KIT	Mar 18, 1992	Unknown	Cypress Medical Products, Ltd.
K875315	I.V. START KITS	Feb 17, 1988	Unknown	Ni-Med, Inc.
K871731	TELSTAR PREWIRE SERIES	Oct 27, 1987	Substantially Equivalent	Telstar Electronics, Inc.
K871281	IV START KIT	May 27, 1987	Substantially Equivalent	The Jarid Group, Inc.
K863796	CREATIVE CARE SYSTEMS' IV START KIT	Nov 28, 1986	Substantially Equivalent	American Biomaterials Corp.
K863712	I.V. START KIT, STERILE, DISPOSABLES	Oct 22, 1986	Substantially Equivalent	Busse Hospital Disposables, Inc.
K852375	I.V. STARTER TRAY W/DYNADERM TRANSPARENT ADHESIVE	Jul 11, 1985	Unknown	Ferris Mfg. Corp.
K844614	IV START KIT	Dec 19, 1984	Substantially Equivalent	Packaging Technologies, Inc.
K842898	CURITY I.V. START KIT	Aug 17, 1984	Substantially Equivalent	The Kendal Co.
K820490	IV START TRAY	Mar 16, 1982	Substantially Equivalent	Seamless Hospital Products Co.
K760876	ARGYLE IV STARTER KIT (W/O DRUG)	Dec 09, 1976	Substantially Equivalent	Sherwood Medical Industries