Cleared Traditional

K953678 - STERIMED STERIZATION WRAPPER (NON-STERILE) (FDA 510(k) Clearance)

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

K953678 · Customed, Inc. · General Hospital
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Oct 1995
Decision
56d
Days
Class 2
Risk

K953678 is an FDA 510(k) clearance for the STERIMED STERIZATION WRAPPER (NON-STERILE). Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Customed, Inc. (Fajardo, US). The FDA issued a Cleared decision on October 2, 1995 after a review of 56 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 Customed, Inc. devices

Submission Details

510(k) Number K953678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1995
Decision Date October 02, 1995
Days to Decision 56 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
72d faster than avg
Panel avg: 128d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRG Wrap, Sterilization
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 - FRG Wrap, Sterilization

All 319
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K953678.
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