Cleared Traditional

K792369 - HYPERALIMENTATION DRESSING TRAY

K792369 is the FDA 510(k) clearance for HYPERALIMENTATION DRESSING TRAY by Pharmaseal Div., Baxter Healthcare Corp.. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K792369 · Pharmaseal Div., Baxter Healthcare Corp. · General Hospital
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Dec 1979
Decision
77d
Days
Class 2
Risk

K792369 is an FDA 510(k) clearance for the HYPERALIMENTATION DRESSING TRAY. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Pharmaseal Div., Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on December 10, 1979 after a review of 77 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 Pharmaseal Div., Baxter Healthcare Corp. devices

Submission Details

510(k) Number K792369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1979
Decision Date December 10, 1979
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
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 123
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K792369.
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
STERILIZER WRAP
K770514 · C.R. Bard, Inc. · Apr 1977
STERIL.WRAP(#221901,2,3,4,5,6,7,8,9)
K760662 · C.R. Bard, Inc. · Dec 1976
STERILIZER WRAP (CAT#221831,2,3,4,5,6)
K760661 · C.R. Bard, Inc. · Dec 1976