Cleared Traditional

K905189 - BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL)

K905189 is an FDA 510(k) clearance for BAXTER ANGIOSCOPY PUMP TUBING SET (MODE..., manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code DQI cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K905189 · Baxter Healthcare Corp · General Hospital
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Jan 1991
Decision
72d
Days
Class 2
Risk

K905189 is an FDA 510(k) clearance for the BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL). Classified as Withdrawal/infusion Pump (product code DQI), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on January 30, 1991 after a review of 72 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 870.1800 - 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K905189

510(k) Number K905189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1990
Decision Date January 30, 1991
Days to Decision 72 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
57d faster than avg
Panel avg: 129d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQI Device Classification - Class 2, Special Controls

Product Code DQI Withdrawal/infusion Pump
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1800
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 - DQI Withdrawal/infusion Pump

Devices cleared under the same product code (DQI) and FDA review panel - the closest regulatory comparables to K905189.
KSEA MODEL 383320 20 ANGIOMAT
K960486 · Karl Storz Endoscopy · Oct 1996
SURGIPUMP
K935763 · W.O.M. World of Medicine GmbH · Apr 1994
USCI SUPER 9 PTCA GUIDING CATHETER
K922541 · C.R. Bard, Inc. · Dec 1992
ANGIOSCOPY PUMP
K895074 · Baxter Healthcare Corp · Jan 1990
OLYMPUS ANGIOSCOPY PUMP
K871422 · Olympus Corp. · Aug 1987