Cleared Traditional

K844030 - ACCUMETER ELECTRONIC URINEMETER SYSTEM

K844030 is an FDA 510(k) clearance for ACCUMETER ELECTRONIC URINEMETER SYSTEM, manufactured by Travenol Laboratories, S.A.. The device is a Class 2 Gastroenterology & Urology device with product code FFG cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K844030 · Travenol Laboratories, S.A. · Gastroenterology & Urology device
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Nov 1984
Decision
36d
Days
Class 2
Risk

K844030 is an FDA 510(k) clearance for the ACCUMETER ELECTRONIC URINEMETER SYSTEM. Classified as Device, Urine Flow Rate Measuring, Non-electrical, Disposable (product code FFG), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on November 20, 1984 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 876.1800 - 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.

FDA 510(k) Submission Details - K844030

510(k) Number K844030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1984
Decision Date November 20, 1984
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
95d faster than avg
Panel avg: 131d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FFG Device Classification - Class 2, Special Controls

Product Code FFG Device, Urine Flow Rate Measuring, Non-electrical, Disposable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1800
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 - FFG Device, Urine Flow Rate Measuring, Non-electrical, Disposable

All 16
Devices cleared under the same product code (FFG) and FDA review panel - the closest regulatory comparables to K844030.
1URO-LOG HOME DIAGNOSTIC PACK
K844338 · Epcom Medical Systems, Inc. · Feb 1985
URINARY DRAINAGE CONTAINER 2012-WITH
K843441 · Vital Metrics, Inc. · Jan 1985
URINARY DRAINAGE CONTAINER 2013 WITH
K843442 · Vital Metrics, Inc. · Jan 1985
UROPUMP MODEL 1711
K843224 · Life-Tech Intl., Inc. · Oct 1984
UROMETER
K833043 · Browne Medical, Inc. · Feb 1984
VITAL METRICS URINE MONITORING SYSTEM
K813641 · Vital Metrics, Inc. · Mar 1982
K844030 · ACCUMETER ELECTRONIC URINEMETER SYSTEM
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