Cleared Traditional

CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS (K972719) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K972719 · Medicel, S.A. DE C.V. · General Hospital
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Feb 1999
Decision
563d
Days
Class 2
Risk

K972719 is an FDA 510(k) clearance for the CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Medicel, S.A. DE C.V. (Rockville, US). The FDA issued a Cleared decision on February 4, 1999 after a review of 563 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital 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 Hospital submissions.

View all Medicel, S.A. DE C.V. devices

Submission Details

510(k) Number K972719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1997
Decision Date February 04, 1999
Days to Decision 563 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
434d slower than avg
Panel avg: 129d · This submission: 563d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 General Hospital devices follow this clearance model.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 135
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K972719.
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