Cleared Traditional

K802044 - AMPCO SKIN SCRUB TRAYS

K802044 · Associated Medical Products Co. · General & Plastic Surgery device
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Sep 1980
Decision
21d
Days
-
Risk

K802044 is an FDA 510(k) clearance for the AMPCO SKIN SCRUB TRAYS, CAT.#SS612.

Submitted by Associated Medical Products Co. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1980 after a review of 21 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 - K802044

510(k) Number K802044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1980
Decision Date September 09, 1980
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
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 K802044.
AMPCO SKIN SCRUB TRAYS, CAT.#SS824
K802042 · Associated Medical Products Co. · Sep 1980
AMPCO SKIN SCRUB TRAYS, CAT.#SS843
K802043 · Associated Medical Products Co. · Sep 1980
PLASTIC DISPOSABLE RAZOR CAT.#1017,1018
K802003 · Pollak (Intl.), Ltd. · Sep 1980
TUBE HOLDER
K801421 · Devon Industries, Inc. · Jul 1980
CONPHAR SURGICAL RAZORR
K791798 · Conphar, Inc. · Feb 1980
CUT-DOWN BUILT-UP TOILET SEAT
K772403 · Fred Sammons, Inc. · Feb 1978