Cleared Traditional

K790969 - ARGYLE URINE METER

K790969 is the FDA 510(k) clearance for ARGYLE URINE METER by Sherwood Medical Co.. It is a Class 2 Gastroenterology & Urology device (product code KNX) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K790969 · Sherwood Medical Co. · Gastroenterology & Urology device
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Jun 1979
Decision
36d
Days
Class 2
Risk

K790969 is an FDA 510(k) clearance for the ARGYLE URINE METER. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on June 27, 1979 after a review of 36 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 Sherwood Medical Co. devices

Submission Details

510(k) Number K790969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1979
Decision Date June 27, 1979
Days to Decision 36 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
94d faster than avg
Panel avg: 130d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 64
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K790969.
CONPHAR LEG BAG-STERILE
K791251 · Conphar, Inc. · Aug 1979
CONPHAR URINARY DRAINAGE BAG 2000ML
K791262 · Conphar, Inc. · Aug 1979
CONPHAR LEG BAG
K791270 · Conphar, Inc. · Aug 1979
BK-6021 CONDOM CATHETER HOLDER
K790174 · Fred Sammons, Inc. · Feb 1979
CATHETER, EXTERNAL MALE NURSING CARE
K781780 · Medi-Tech, Inc. · Dec 1978
CUTTER RESIFLEX URINE METER
K781521 · Cutter Laboratories, Inc. · Nov 1978