Cleared Traditional

K884397 - PHARMASEAL STERILE WOUND CARE DRESSING

K884397 · Baxter Healthcare Corp · General & Plastic Surgery device
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Dec 1988
Decision
69d
Days
-
Risk

K884397 is an FDA 510(k) clearance for the PHARMASEAL STERILE WOUND CARE DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on December 27, 1988 after a review of 69 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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.

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FDA 510(k) Submission Details - K884397

510(k) Number K884397 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 19, 1988
Decision Date December 27, 1988
Days to Decision 69 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 500
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K884397.
WATER JEL STERILE GEL-SOAKED BURN DRESSING
K892360 · Pfizer, Inc. · Jun 1989
ACTIDERM*-OPAQUE
K892232 · Convatec, A Division of E.R. Squibb & Sons · May 1989
PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH
K885045 · Baxter Healthcare Corp · Mar 1989
SKINCOTE
K882567 · Dynarex Corp. · Oct 1988
COMPEED ATHLETIC DRESSING
K883588 · Coloplast A/S · Sep 1988
HYDROCOLLOID DRESSING FOR PSORIASIS
K881039 · Hollister, Inc. · Jun 1988