Cleared Traditional

K902157 - JOHNSON & JOHNSON DUAL SYRINGE APPLICATOR

K902157 is an FDA 510(k) clearance for JOHNSON & JOHNSON DUAL SYRINGE APPLICATOR, manufactured by Johnson & Johnson Medical, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K902157 · Johnson & Johnson Medical, Inc. · General Hospital
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Nov 1990
Decision
198d
Days
Class 2
Risk

K902157 is an FDA 510(k) clearance for the JOHNSON & JOHNSON DUAL SYRINGE APPLICATOR. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Johnson & Johnson Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on November 29, 1990 after a review of 198 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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.

FDA 510(k) Submission Details - K902157

510(k) Number K902157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 15, 1990
Decision Date November 29, 1990
Days to Decision 198 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 129d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 755
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K902157.
DAVID SIMMONDS ANESTHESIA EXTENSION TUBES
K905384 · Sparta Surgical Corp. · Mar 1991
STERAID DISPOSABLE SYRINGE
K904620 · Disposable Medi-Aids , Ltd. · Mar 1991
YUEFA DISPOSABLE SYRINGE
K902178 · Blue & Red Corp. · Dec 1990
SAFE-T-STIK
K904382 · Xikon Technology · Oct 1990
INSULIN SYRINGE GUIDE
K903426 · Bay State Anesthesia, Inc. · Sep 1990
SHARGHP SYRINGES, WITH AND WITHOUT NEEDLE
K895810 · Shargh Pharmaceutical Co., Inc. · Sep 1990
K902157 · JOHNSON & JOHNSON DUAL SYRINGE APPLICATOR
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