Cleared Traditional

K801569 - VAL-U-WRAP CSR WRAP

K801569 is an FDA 510(k) clearance for VAL-U-WRAP CSR WRAP, manufactured by American Convertors Div., American Pharmaseal. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K801569 · American Convertors Div., American Pharmaseal · General Hospital
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Jul 1980
Decision
20d
Days
Class 2
Risk

K801569 is an FDA 510(k) clearance for the VAL-U-WRAP CSR WRAP. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by American Convertors Div., American Pharmaseal (Mchenry, US). The FDA issued a Cleared decision on July 28, 1980 after a review of 20 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 American Convertors Div., American Pharmaseal devices

FDA 510(k) Submission Details - K801569

510(k) Number K801569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1980
Decision Date July 28, 1980
Days to Decision 20 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 129d · This submission: 20d
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 234
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K801569.
PROPPER SHARPGUARD & TRAYPAD STERIL. AID
K802428 · Propper Mfg. Co., Inc. · Oct 1980
AMPCO DRESSING CHANGE TRAYS
K801333 · Associated Medical Products Co. · Aug 1980
AMPCO HYPERALIMENTATION SUBCLAVIAN TRAYS
K801331 · Associated Medical Products Co. · Aug 1980
AMPCO SKIN SCRUB TRAYS
K801332 · Associated Medical Products Co. · Jun 1980
HYPERALIMENTATION DRESSING TRAY
K792369 · Pharmaseal Div., Baxter Healthcare Corp. · Dec 1979
AUTOCLAVE POUCHES&ROLLS/STEAM&GAS
K780034 · E.M. Adams · Feb 1978