Cleared Traditional

IRRIGATING SYRINGE (K912437) - FDA 510(k) Clearance

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

K912437 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
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Jul 1992
Decision
406d
Days
Class 2
Risk

K912437 is an FDA 510(k) clearance for the IRRIGATING SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on July 13, 1992 after a review of 406 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K912437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1991
Decision Date July 13, 1992
Days to Decision 406 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
277d slower than avg
Panel avg: 129d · This submission: 406d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 222
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K912437.
BECTON DICKINSON SAFETY-LOK SYRINGE
K924072 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1992
MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES
K922522 · Sherwood Medical Co. · Nov 1992
ENDOPATH ENDO-SURGERY PERCUTANEOUS CATHETER INTROD
K921833 · Ethicon, Inc. · Sep 1992
B-D INTERLINK SYRINGE CANNULA
K920422 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
BECTON DICKINSON SAFETY-LOK SYRINGE
K920321 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
B-D(TM) MICROFINE(TM) IV PEN INJECTOR CAT. #328204
K912330 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991