Cleared Traditional

K903816 - URINE METER FOLEY TRAY WITH TEMPERATURE...

K903816 is an FDA 510(k) clearance for URINE METER FOLEY TRAY WITH TEMPERATURE..., manufactured by Respiratory Support Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZK cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K903816 · Respiratory Support Products, Inc. · Gastroenterology & Urology device
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Oct 1990
Decision
72d
Days
Class 2
Risk

K903816 is an FDA 510(k) clearance for the URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR. Classified as Catheter, Retention Type (product code EZK), Class II - Special Controls.

Submitted by Respiratory Support Products, Inc. (Irvine, US). The FDA issued a Cleared decision on October 31, 1990 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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 Respiratory Support Products, Inc. devices

FDA 510(k) Submission Details - K903816

510(k) Number K903816 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received August 20, 1990
Decision Date October 31, 1990
Days to Decision 72 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
58d faster than avg
Panel avg: 130d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZK Device Classification - Class 2, Special Controls

Product Code EZK Catheter, Retention Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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.