Cleared Traditional

K870531 - EZ TAC FILTER

K870531 is an FDA 510(k) clearance for EZ TAC FILTER, manufactured by John F. Greer Co., Inc.. The device is a Class 1 Gastroenterology & Urology device with product code EXB cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K870531 · John F. Greer Co., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1987
Decision
63d
Days
Class 1
Risk

K870531 is an FDA 510(k) clearance for the EZ TAC FILTER. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by John F. Greer Co., Inc. (Oakland, US). The FDA issued a Cleared decision on April 10, 1987 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5900 - 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 John F. Greer Co., Inc. devices

FDA 510(k) Submission Details - K870531

510(k) Number K870531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1987
Decision Date April 10, 1987
Days to Decision 63 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
67d faster than avg
Panel avg: 130d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

EXB Device Classification - Class 1, General Controls

Product Code EXB Collector, Ostomy
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EXB Collector, Ostomy

All 69
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K870531.
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