Cleared Traditional

K902588 - BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VE...

K902588 is an FDA 510(k) clearance for BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VE..., manufactured by Gambro-Hospal, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K902588 · Gambro-Hospal, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 1991
Decision
268d
Days
Class 2
Risk

K902588 is an FDA 510(k) clearance for the BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Gambro-Hospal, Inc. (Williamsburg, US). The FDA issued a Cleared decision on March 7, 1991 after a review of 268 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gambro-Hospal, Inc. devices

FDA 510(k) Submission Details - K902588

510(k) Number K902588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1990
Decision Date March 07, 1991
Days to Decision 268 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 130d · This submission: 268d
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 123
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K902588.
MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG
K911106 · Baxter Healthcare Corp · May 1991
INTRODUCER NEEDLES
K910641 · Akcess Medical Products, Inc. · Apr 1991
Y ADAPTOR
K910321 · Akcess Medical Products, Inc. · Apr 1991
MODIFIED LABELING TO MODEL 9608 ARTERIAL HEMO BLD.
K895244 · National Medical Care, Medical Products Div., Inc. · Feb 1990
DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095
K896006 · Baxter Healthcare Corp · Dec 1989
NATIONAL MEDICAL CARE VENOUS LINE 03-9548
K894637 · National Medical Care, Medical Products Div., Inc. · Sep 1989