Cleared Traditional

K771667 - BLOOD GAS TRAY #4024

K771667 is an FDA 510(k) clearance for BLOOD GAS TRAY #4024, manufactured by Concord Laboratories, Inc.. The device is a Class 2 Hematology device with product code FMI cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K771667 · Concord Laboratories, Inc. · Hematology device
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Oct 1977
Decision
43d
Days
Class 2
Risk

K771667 is an FDA 510(k) clearance for the BLOOD GAS TRAY #4024. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Concord Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 13, 1977 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 880.5570 - 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 Concord Laboratories, Inc. devices

FDA 510(k) Submission Details - K771667

510(k) Number K771667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1977
Decision Date October 13, 1977
Days to Decision 43 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
70d faster than avg
Panel avg: 113d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

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 Hematology devices follow this clearance model.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 337
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K771667.
DOUBLE ENDED VENTED TRANSFER DEVICE
K801108 · Burron Medical Products, Inc. · May 1980
AMIPAQUE MYELOGRAM TRAY
K791156 · Pharmaseal Div., Baxter Healthcare Corp. · Jul 1979
NEEDLE, TRUCARE VACUTAINER
K790086 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1979
TERUFUSION BLOOD ADMIN. SET
K771209 · Terumo America, Inc. · Jul 1977
DISP. HYPODERMIC NEEDLE
K771203 · Terumo America, Inc. · Jul 1977
TERUFUSION DONOR SET
K771207 · Terumo America, Inc. · Jul 1977