Cleared Traditional

K822916 - UROCOMP REMOTE CONTROL 1804

K822916 is an FDA 510(k) clearance for UROCOMP REMOTE CONTROL 1804, manufactured by Life-Tech Intl., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAP cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K822916 · Life-Tech Intl., Inc. · Gastroenterology & Urology device
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Dec 1982
Decision
73d
Days
Class 2
Risk

K822916 is an FDA 510(k) clearance for the UROCOMP REMOTE CONTROL 1804. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by Life-Tech Intl., Inc. (Houston, US). The FDA issued a Cleared decision on December 13, 1982 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1620 - 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 Life-Tech Intl., Inc. devices

FDA 510(k) Submission Details - K822916

510(k) Number K822916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1982
Decision Date December 13, 1982
Days to Decision 73 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
57d faster than avg
Panel avg: 130d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAP Device Classification - Class 2, Special Controls

Product Code FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1620
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 - FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device

All 24
Devices cleared under the same product code (FAP) and FDA review panel - the closest regulatory comparables to K822916.
1870T PRESSURE TRANSDUCER PRE-AMPLIFIER, 1880 WATE
K850602 · Life-Tech Intl., Inc. · Apr 1985
LUMEN-4 URODYNAMIC CATHETER
K833628 · Surgitek · Nov 1983
URETHRAL PRESSURE PROFILE & TEMP. MODUL
K823561 · Nihon Kohden America, Inc. · Jan 1983
1512M/F WIRE ELECTRODE NEEDLE SET
K823432 · Life-Tech Intl., Inc. · Nov 1982
UROCOMP MODEL 1404
K821939 · Life-Tech Intl., Inc. · Jul 1982
ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2
K790519 · American Medical Systems, Inc. · May 1979