Cleared Traditional

K920737 - LIFESHIELD VIAL ADAPTER

K920737 is an FDA 510(k) clearance for LIFESHIELD VIAL ADAPTER, manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K920737 · Abbott Laboratories · General Hospital
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Dec 1992
Decision
300d
Days
Class 2
Risk

K920737 is an FDA 510(k) clearance for the LIFESHIELD VIAL ADAPTER. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 15, 1992 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K920737

510(k) Number K920737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1992
Decision Date December 15, 1992
Days to Decision 300 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 129d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 271
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K920737.
BARD SAFE SAMPLING DEVICE
K925446 · C.R. Bard, Inc. · Jul 1993
B-D PEN NEEDLE
K924070 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1993
BECTON DICKINSON INTERLINK VIAL ACCESS CANNULA
K924439 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1993
DISPOSABLE INTROSSEOUS INFUSION NEEDLES
K913258 · Cook, Inc. · Mar 1992
INTRAOSSEOUS ACCESS NEEDLE
K915409 · Cook, Inc. · Mar 1992
CHEMO-PORT
K913386 · Hdc Corp. · Jan 1992