Cleared Traditional

K885045 - PHARMACLENS LOW ABRASION WOUND SPONGE/B...

K885045 · Baxter Healthcare Corp · General & Plastic Surgery device

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Mar 1989

Decision

88d

Days

Risk

K885045 is an FDA 510(k) clearance for the PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on March 3, 1989 after a review of 88 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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Submission Details

510(k) Number	K885045 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 05, 1988
Decision Date	March 03, 1989
Days to Decision	88 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

27d faster than avg

Panel avg: 115d · This submission: 88d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	FRO Dressing, Wound, Drug
Device Class	-

Regulatory Peers - FRO Dressing, Wound, Drug

All 222

Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K885045.

CUTINOVA(R) PLUS ON VASCULAR STASIS ULCERS

K885279 · Beiersdorf, Inc. · Jun 1989

TEGASORB(TM) ULCER DRESSING, #90-XXX

K891288 · 3M Company · Jun 1989

ACTIDERM*-OPAQUE

K892232 · Convatec, A Division of E.R. Squibb & Sons · May 1989

PHARMASEAL STERILE WOUND CARE DRESSING

K884397 · Baxter Healthcare Corp · Dec 1988

COMPEED ATHLETIC DRESSING

K883588 · Coloplast A/S · Sep 1988

HYDROCOLLOID DRESSING FOR PSORIASIS

K881039 · Hollister, Inc. · Jun 1988

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K885045

Baxter Healthcare Corp

Valencia, CA · US

T MERRICK

Regulatory profile

505 submissions 496 cleared

98% clearance rate · Active in General & Plastic Surgery

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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