Cleared Traditional

K913361 - DRAIN/PRIMING/RECIRCULATION BAG

K913361 is an FDA 510(k) clearance for DRAIN/PRIMING/RECIRCULATION BAG, manufactured by Haemotronic, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K913361 · Haemotronic, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 1992
Decision
245d
Days
Class 2
Risk

K913361 is an FDA 510(k) clearance for the DRAIN/PRIMING/RECIRCULATION BAG. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Haemotronic, Inc. (Fairfield, US). The FDA issued a Cleared decision on March 30, 1992 after a review of 245 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 Haemotronic, Inc. devices

FDA 510(k) Submission Details - K913361

510(k) Number K913361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1991
Decision Date March 30, 1992
Days to Decision 245 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 130d · This submission: 245d
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 K913361.
BARD UROTRACK II MONITORING
K924436 · C.R. Bard, Inc. · Mar 1994
RS-1000
K911230 · Cp Medical · Jun 1993
BARD(R) UROTACK(R) 210 MONITORING SYSTEM
K912374 · C.R. Bard, Inc. · Mar 1992
EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT
K911315 · Baxter Healthcare Corp · Oct 1991
MINNILERT(R) PRESSURE MONITOR
K913483 · Minntech Corp. · Sep 1991
MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG
K911106 · Baxter Healthcare Corp · May 1991