Cleared Traditional

K891213 - SURGICAL INSTRUMENT POUCH #M102

K891213 is an FDA 510(k) clearance for SURGICAL INSTRUMENT POUCH #M102, manufactured by Pro-Safe Professional Linens, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K891213 · Pro-Safe Professional Linens, Inc. · General Hospital
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Apr 1989
Decision
38d
Days
Class 2
Risk

K891213 is an FDA 510(k) clearance for the SURGICAL INSTRUMENT POUCH #M102. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Pro-Safe Professional Linens, Inc. (Grand Junction, US). The FDA issued a Cleared decision on April 14, 1989 after a review of 38 days - a notably fast clearance cycle.

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: 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 Pro-Safe Professional Linens, Inc. devices

FDA 510(k) Submission Details - K891213

510(k) Number K891213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1989
Decision Date April 14, 1989
Days to Decision 38 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 129d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KCT Device Classification - Class 2, Special Controls

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 243
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K891213.
BARRIER PLASTIC PACKAGING (MODIFICATION)
K933560 · Maxxim Medical · Apr 1994
SHAVE PREP TRAY
K935739 · Cush Medical Products · Feb 1994
CAM-WRAP(TM) NEW STERILIZATION PROCEDURE
K891983 · Medical Dynamics, Inc. · Apr 1989
THE KEYMED FIBERSCOPE STERILIZATION CASE
K860528 · Keymed, Inc. · Jul 1986
MICROVASIVE SILICONE SPRAY
K854063 · Microvasive · Oct 1985
INSTRUMENT GUARD CAPSULE
K831588 · Treace Medical, Inc. · Jun 1983