Cleared Traditional

K872743 - BAXA TUBING SETS (FOR PHARMACY PUMP)

K872743 is an FDA 510(k) clearance for BAXA TUBING SETS (FOR PHARMACY PUMP), manufactured by Baxa Corp., Sub. of Cook Group, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K872743 · Baxa Corp., Sub. of Cook Group, Inc. · General Hospital
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Oct 1987
Decision
88d
Days
Class 2
Risk

K872743 is an FDA 510(k) clearance for the BAXA TUBING SETS (FOR PHARMACY PUMP). Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Baxa Corp., Sub. of Cook Group, Inc. (Englewood, US). The FDA issued a Cleared decision on October 9, 1987 after a review of 88 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 Baxa Corp., Sub. of Cook Group, Inc. devices

FDA 510(k) Submission Details - K872743

510(k) Number K872743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1987
Decision Date October 09, 1987
Days to Decision 88 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 129d · This submission: 88d
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 538
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K872743.
DISPOSABLE SYRINGE
K882335 · Baxter Healthcare Corp · Jun 1988
MEDSURG MYELOGRAM TRAY
K880693 · Medsurg Industries, Inc. · May 1988
ALLERGIST SYRINGES
K880894 · Abco Dealers, Inc. · Mar 1988
JMS NEEDLES AND JMS SYRINGES
K871965 · Jms Co., Ltd. · Sep 1987
SAFETY SYRINGE
K872820 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1987
LOOK SPRING-ASSIST SYRINGES
K872944 · Look, Inc. · Sep 1987