Cleared Traditional

SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536 (K901922) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K901922 · Safte S.P.A. · Gastroenterology & Urology device
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Oct 1990
Decision
179d
Days
Class 1
Risk

K901922 is an FDA 510(k) clearance for the SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536. Classified as Support, Hernia (product code EXN), Class I - General Controls.

Submitted by Safte S.P.A. (Italia, IT). The FDA issued a Cleared decision on October 26, 1990 after a review of 179 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5970 - 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 Safte S.P.A. devices

Submission Details

510(k) Number K901922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1990
Decision Date October 26, 1990
Days to Decision 179 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
49d slower than avg
Panel avg: 130d · This submission: 179d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EXN Support, Hernia
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5970
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.