Cleared Traditional

K802041 - AMPCO SHAVE PREP TRAYS

K802041 · Associated Medical Products Co. · General & Plastic Surgery device
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Oct 1980
Decision
65d
Days
-
Risk

K802041 is an FDA 510(k) clearance for the AMPCO SHAVE PREP TRAYS, CAT.#SP4020.

Submitted by Associated Medical Products Co. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 65 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 - K802041

510(k) Number K802041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1980
Decision Date October 23, 1980
Days to Decision 65 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
50d faster than avg
Panel avg: 115d · This submission: 65d
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 K802041.
POSTURE MIRROR
K812479 · Maddak, Inc. · Dec 1981
FOAM WEDGE
K812482 · Maddak, Inc. · Sep 1981
DRESSING CHANGE TRAY-MEDIUM
K810570 · Associated Medical Products Co. · Mar 1981
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
AMPCO SKIN SCRUB TRAYS, CAT.#SS843
K802043 · Associated Medical Products Co. · Sep 1980