Cleared Traditional

K871738 - OSTO-PURE

K871738 is an FDA 510(k) clearance for OSTO-PURE, manufactured by Clearchem Corp.. The device is a Class 1 Gastroenterology & Urology device with product code EXB cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K871738 · Clearchem Corp. · Gastroenterology & Urology device
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Aug 1987
Decision
99d
Days
Class 1
Risk

K871738 is an FDA 510(k) clearance for the OSTO-PURE. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Clearchem Corp. (Lima, US). The FDA issued a Cleared decision on August 12, 1987 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Clearchem Corp. devices

FDA 510(k) Submission Details - K871738

510(k) Number K871738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1987
Decision Date August 12, 1987
Days to Decision 99 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
31d faster than avg
Panel avg: 130d · This submission: 99d
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
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