Cleared Traditional

K802043 - AMPCO SKIN SCRUB TRAYS

K802043 · Associated Medical Products Co. · General & Plastic Surgery device

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Sep 1980

Decision

28d

Days

Risk

K802043 is an FDA 510(k) clearance for the AMPCO SKIN SCRUB TRAYS, CAT.#SS843.

Submitted by Associated Medical Products Co. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 after a review of 28 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.

View all Associated Medical Products Co. devices

FDA 510(k) Submission Details - K802043

510(k) Number	K802043 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 19, 1980
Decision Date	September 16, 1980
Days to Decision	28 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

87d faster than avg

Panel avg: 115d · This submission: 28d

Pathway characteristics

Predicate-based equivalence.

LDQ Device Classification - Class ,

Product Code	LDQ
Device Class	-

Regulatory Peers - LDQ

All 23

Devices cleared under the same product code (LDQ) and FDA review panel - the closest regulatory comparables to K802043.

AMPCO SHAVE PREP TRAYS, CAT.#SP4020

K802041 · Associated Medical Products Co. · Oct 1980

NU-BORN BABY BATH KIT

K802366 · American Hospital Supply Corp. · Oct 1980

AMPCO SKIN SCRUB TRAYS, CAT.#SS824

K802042 · Associated Medical Products Co. · Sep 1980

PLASTIC DISPOSABLE RAZOR CAT.#1017,1018

K802003 · Pollak (Intl.), Ltd. · Sep 1980

AMPCO SKIN SCRUB TRAYS, CAT.#SS612

K802044 · Associated Medical Products Co. · Sep 1980

TUBE HOLDER

K801421 · Devon Industries, Inc. · Jul 1980

FDA 510(k) Resources - General & Plastic Surgery

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

Manufacturer of K802043

Associated Medical Products Co.

Mchenry, IL · US

Regulatory profile

29 submissions 23 cleared

79% clearance rate · Active in General & Plastic Surgery

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

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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