Cleared Traditional

K933550 - HYDRASPUN M STERILIZATION WRAP

K933550 is an FDA 510(k) clearance for HYDRASPUN M STERILIZATION WRAP, manufactured by Ahlstrom Dexter. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K933550 · Ahlstrom Dexter · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
251d
Days
Class 2
Risk

K933550 is an FDA 510(k) clearance for the HYDRASPUN M STERILIZATION WRAP. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Ahlstrom Dexter (Windsor Locks, US). The FDA issued a Cleared decision on March 29, 1994 after a review of 251 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Ahlstrom Dexter devices

FDA 510(k) Submission Details - K933550

510(k) Number K933550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1993
Decision Date March 29, 1994
Days to Decision 251 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 129d · This submission: 251d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

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 239
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K933550.
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