Cleared Traditional

LIFESHIELD VIAL ADAPTER (K920737) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 196
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
VIAL ACCESS CANNULA
K905664 · Baxter Healthcare Corp · Mar 1991