Cleared Traditional

K911106 - MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG

K911106 is an FDA 510(k) clearance for MODEL BAXTER ULTRAFILTRATE METER AND DR..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K911106 · Baxter Healthcare Corp · Gastroenterology & Urology device
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May 1991
Decision
77d
Days
Class 2
Risk

K911106 is an FDA 510(k) clearance for the MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on May 28, 1991 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology 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.

FDA 510(k) Submission Details - K911106

510(k) Number K911106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1991
Decision Date May 28, 1991
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 131d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOC Device Classification - Class 2, Special Controls

Product Code KOC Accessories, Blood Circuit, Hemodialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KOC Accessories, Blood Circuit, Hemodialysis

All 181
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K911106.
DRAIN/PRIMING/RECIRCULATION BAG
K913361 · Haemotronic, Inc. · Mar 1992
EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT
K911315 · Baxter Healthcare Corp · Oct 1991
MINNILERT(R) PRESSURE MONITOR
K913483 · Minntech Corp. · Sep 1991
INTRODUCER NEEDLES
K910641 · Akcess Medical Products, Inc. · Apr 1991
Y ADAPTOR
K910321 · Akcess Medical Products, Inc. · Apr 1991
BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD
K902588 · Gambro-Hospal, Inc. · Mar 1991
K911106 · MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG
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