Cleared Traditional

UROTRON (K781632) - FDA 510(k) Clearance

Class I Chemistry device.

K781632 · Boehringer Mannheim Corp. · Chemistry device
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Dec 1978
Decision
86d
Days
Class 1
Risk

K781632 is an FDA 510(k) clearance for the UROTRON. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on December 20, 1978 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - the FDA in vitro diagnostics and chemistry 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 Boehringer Mannheim Corp. devices

Submission Details

510(k) Number K781632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1978
Decision Date December 20, 1978
Days to Decision 86 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 88d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 44
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K781632.
AMES GLUCOMETER REFLECT. PHOTOMETER
K801044 · Miles Laboratories, Inc. · Jun 1980
AMES DEXTROMETER REFLECTANCE COLORIMETER
K792292 · Miles Laboratories, Inc. · Dec 1979
HEMESPEC
K782035 · Helena Laboratories · Jan 1979
DUAL WAVELENGTH PHOTOMETER, 1177
K771909 · Abbott Laboratories · Dec 1977
CHEMCODE/CHEMTEK SYSTEM
K771496 · Boehringer Mannheim Corp. · Oct 1977
PRINTER, IL 460
K760232 · Instrumentation Laboratory CO · Aug 1976