Cleared Traditional

K772338 - SYRINGE

K772338 is the FDA 510(k) clearance for SYRINGE by C.R. Bard, Inc.. It is a Class 2 Hematology device (product code FMF) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K772338 · C.R. Bard, Inc. · Hematology device
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Jan 1978
Decision
35d
Days
Class 2
Risk

K772338 is an FDA 510(k) clearance for the SYRINGE, BLOOD, SAMPLING, ARTERIAL. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1978 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 880.5860 - the FDA hematology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K772338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1977
Decision Date January 26, 1978
Days to Decision 35 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 113d · This submission: 35d
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 Hematology devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 285
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K772338.
MINI-IRRIGATION TRAY
K780595 · Abco Dealers, Inc. · Apr 1978
IRRIGATION TRAY
K780600 · Abco Dealers, Inc. · Apr 1978
SYRINGE (IRRIGATION)
K780602 · Abco Dealers, Inc. · Apr 1978
SYRINGE, DISPOSABLE
K771888 · Orthopedic Equipment Co., Inc. · Oct 1977
ARTEOIAL BLOOD SAMPLING KIT 2D9014
K771584 · Travenol Laboratories, S.A. · Sep 1977
TRAY, BLOOD GAS, ARTERIAL, #4014
K770850 · Concord Laboratories, Inc. · Jul 1977