Cleared Traditional

K873875 - BAXA EXACTA-MED PHARMACY PUMP

K873875 is an FDA 510(k) clearance for BAXA EXACTA-MED PHARMACY PUMP, manufactured by Baxa Corp., Sub. of Cook Group, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K873875 · Baxa Corp., Sub. of Cook Group, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1987
Decision
63d
Days
Class 2
Risk

K873875 is an FDA 510(k) clearance for the BAXA EXACTA-MED PHARMACY PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Baxa Corp., Sub. of Cook Group, Inc. (Englewood, US). The FDA issued a Cleared decision on November 24, 1987 after a review of 63 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 - K873875

510(k) Number K873875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1987
Decision Date November 24, 1987
Days to Decision 63 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
66d faster than avg
Panel avg: 129d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 615
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K873875.
IVAC(R) DUAL RATE SET - MODEL C50066
K873938 · Y · Dec 1987
CORMED III AMBULATORY INFUSION PUMP
K873847 · C.R. Bard, Inc. · Dec 1987
IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580+
K873776 · Y · Dec 1987
VALLEYLAB MODEL IV7200 INFUSION PUMP
K873161 · Valleylab, Inc. · Nov 1987
IVAC NITROGLYCERIN & LIPID ADMIN. SET MODEL S75053
K872764 · Y · Nov 1987
IMED(R) 980C VOLUMETRIC INFUSION PUMP
K870656 · Imed Corp. · Oct 1987