Cleared Traditional

K831412 - CRM-100 COLOR VIDEO CAMERA

K831412 is an FDA 510(k) clearance for CRM-100 COLOR VIDEO CAMERA, manufactured by Umi, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FET cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K831412 · Umi, Inc. · Gastroenterology & Urology device
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Jun 1983
Decision
32d
Days
Class 2
Risk

K831412 is an FDA 510(k) clearance for the CRM-100 COLOR VIDEO CAMERA. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Umi, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 3, 1983 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Umi, Inc. devices

FDA 510(k) Submission Details - K831412

510(k) Number K831412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1983
Decision Date June 03, 1983
Days to Decision 32 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 131d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FET Device Classification - Class 2, Special Controls

Product Code FET Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.
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 - FET Endoscopic Video Imaging System/component, Gastroenterology-urology

All 77
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K831412.
OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM)
K870680 · Medline Industries, Inc. · Apr 1987
OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS
K853585 · Olympus Corp. · Jan 1986
VIDEO URODYNAMICS SYS 1906B-Y & 1906C-Y
K843198 · Life-Tech Intl., Inc. · Oct 1984
ENDOSCOPIC CLOSED CIRCUIT COLOR TV SYST.
K810393 · Keymed, Inc. · Mar 1981