Cleared Traditional

K853936 - 1351 UROFLOW AUTO START

K853936 is an FDA 510(k) clearance for 1351 UROFLOW AUTO START, 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 69-day FDA review.

K853936 · Life-Tech Intl., Inc. · Gastroenterology & Urology device
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Dec 1985
Decision
69d
Days
Class 2
Risk

K853936 is an FDA 510(k) clearance for the 1351 UROFLOW AUTO START. 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 2, 1985 after a review of 69 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 - K853936

510(k) Number K853936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1985
Decision Date December 02, 1985
Days to Decision 69 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
61d faster than avg
Panel avg: 130d · This submission: 69d
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 K853936.
MODEL 1101M & 1151M UROLAB MICRO URODYNAMIC RECORD
K863168 · Life-Tech Intl., Inc. · Oct 1986
MODEL AS-72 ADMINISTRATION SET
K863169 · Life-Tech Intl., Inc. · Sep 1986
MODEL RCV REFLUX CHECK VALVE
K862327 · Life-Tech Intl., Inc. · Sep 1986
MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR
K850601 · Life-Tech Intl., Inc. · Apr 1985
1870T PRESSURE TRANSDUCER PRE-AMPLIFIER, 1880 WATE
K850602 · Life-Tech Intl., Inc. · Apr 1985
LUMEN-4 URODYNAMIC CATHETER
K833628 · Surgitek · Nov 1983