Cleared Traditional

K770497 - DRAINAGE UNIT, COMBINATION

K770497 is an FDA 510(k) clearance for DRAINAGE UNIT, manufactured by Concord Laboratories, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K770497 · Concord Laboratories, Inc. · Gastroenterology & Urology device
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Mar 1977
Decision
7d
Days
Class 2
Risk

K770497 is an FDA 510(k) clearance for the DRAINAGE UNIT, COMBINATION. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Concord Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 21, 1977 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5250 - 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.

View all Concord Laboratories, Inc. devices

FDA 510(k) Submission Details - K770497

510(k) Number K770497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1977
Decision Date March 21, 1977
Days to Decision 7 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
124d faster than avg
Panel avg: 131d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNX Device Classification - Class 2, Special Controls

Product Code KNX Collector, Urine, (and Accessories) For Indwelling Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5250
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 - KNX Collector, Urine, (and Accessories) For Indwelling Catheter

All 100
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K770497.
MEMBRANE SOURCE-EX SERIES DIALYZER CART.
K770516 · Extracorporeal Medical Specialities, Inc. · Mar 1977
DRAINAGE BAG, 4000 ML.
K770557 · Concord Laboratories, Inc. · Mar 1977
DRAINAGE BAG, IMPROVED, FLAT
K770490 · Pharmaseal Div., Baxter Healthcare Corp. · Mar 1977
URINARY DRAINAGE SET, CLOSED, STERILE
K770320 · Medical Devices, Inc. · Mar 1977
URINARY LEG BAG DRAINAGE TUBE
K761039 · Pharmaseal Div., Baxter Healthcare Corp. · Dec 1976
BAG, LEG, URINE COLLECTING DEVICE
K760069 · Pharmaseal Div., Baxter Healthcare Corp. · Oct 1976