Cleared Traditional

PRESTITCH (K910449) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K910449 · Crantec Co. · General & Plastic Surgery device
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May 1992
Decision
486d
Days
Class 1
Risk

K910449 is an FDA 510(k) clearance for the PRESTITCH. Classified as Tourniquet, Pneumatic (product code KCY), Class I - General Controls.

Submitted by Crantec Co. (Salt Lake City, US). The FDA issued a Cleared decision on May 29, 1992 after a review of 486 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5910 - the FDA general and plastic surgery 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Crantec Co. devices

Submission Details

510(k) Number K910449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1991
Decision Date May 29, 1992
Days to Decision 486 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
371d slower than avg
Panel avg: 115d · This submission: 486d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KCY Tourniquet, Pneumatic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.5910
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.