Cleared Traditional

K771763 - HEMO-RO

K771763 is an FDA 510(k) clearance for HEMO-RO, manufactured by Millipore Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K771763 · Millipore Corp. · Gastroenterology & Urology device
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Oct 1977
Decision
15d
Days
Class 2
Risk

K771763 is an FDA 510(k) clearance for the HEMO-RO. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Millipore Corp. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1977 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5665 - 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 Millipore Corp. devices

FDA 510(k) Submission Details - K771763

510(k) Number K771763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1977
Decision Date October 04, 1977
Days to Decision 15 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
115d faster than avg
Panel avg: 130d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIP Device Classification - Class 2, Special Controls

Product Code FIP Subsystem, Water Purification
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5665
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.