Cleared Traditional

K770851 - SYRINGE, BLOOD SAMPLING, ARTERIAL, #4016

K770851 is an FDA 510(k) clearance for SYRINGE, manufactured by Concord Laboratories, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K770851 · Concord Laboratories, Inc. · General Hospital
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Jul 1977
Decision
66d
Days
Class 2
Risk

K770851 is an FDA 510(k) clearance for the SYRINGE, BLOOD SAMPLING, ARTERIAL, #4016. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Concord Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 14, 1977 after a review of 66 days - a notably fast clearance 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: 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 Concord Laboratories, Inc. devices

FDA 510(k) Submission Details - K770851

510(k) Number K770851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1977
Decision Date July 14, 1977
Days to Decision 66 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
63d faster than avg
Panel avg: 129d · This submission: 66d
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 368
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K770851.
ARTEOIAL BLOOD SAMPLING KIT 2D9014
K771584 · Travenol Laboratories, S.A. · Sep 1977
ALLERGIST PACK SYRINGES
K771359 · Pharmaseal Div., Baxter Healthcare Corp. · Aug 1977
TRAY, BLOOD GAS, ARTERIAL, #4014
K770850 · Concord Laboratories, Inc. · Jul 1977
SYRINGE, BLOOD SAMPLING, ARTERIAL, #4015
K770852 · Concord Laboratories, Inc. · Jul 1977
HYPODERMIC SYRINGE
K771205 · Terumo America, Inc. · Jul 1977
OVERDOSE KIT
K770238 · American Hospital Supply Corp. · Apr 1977