Cleared Traditional

K770475 - PRESSURE TRANSDUCER ISOLATER CODE 5ML6L2

K770475 is the FDA 510(k) clearance for PRESSURE TRANSDUCER ISOLATER CODE 5ML6L2 by Travenol Laboratories, S.A.. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 5-day FDA review.

K770475 · Travenol Laboratories, S.A. · Gastroenterology & Urology device
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Mar 1977
Decision
5d
Days
Class 2
Risk

K770475 is an FDA 510(k) clearance for the PRESSURE TRANSDUCER ISOLATER CODE 5ML6L2. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on March 16, 1977 after a review of 5 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K770475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1977
Decision Date March 16, 1977
Days to Decision 5 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
125d faster than avg
Panel avg: 130d · This submission: 5d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOC Accessories, Blood Circuit, Hemodialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 114
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K770475.
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DNC 161 VINCA-FLO
K770043 · Sorensen Research · Jan 1977