Cleared Traditional

K802570 - A.M.P.C.O. SKIN SCRUB TRAY

K802570 is an FDA 510(k) clearance for A.M.P.C.O. SKIN SCRUB TRAY, manufactured by Associated Medical Products Co.. The device is a Class 1 General & Plastic Surgery device with product code FSM cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K802570 · Associated Medical Products Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1980
Decision
28d
Days
Class 1
Risk

K802570 is an FDA 510(k) clearance for the A.M.P.C.O. SKIN SCRUB TRAY. Classified as Tray, Surgical, Instrument (product code FSM), Class I - General Controls.

Submitted by Associated Medical Products Co. (Mchenry, US). The FDA issued a Cleared decision on November 14, 1980 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. 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 - K802570

510(k) Number K802570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1980
Decision Date November 14, 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.

FSM Device Classification - Class 1, General Controls

Product Code FSM Tray, Surgical, Instrument
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FSM Tray, Surgical, Instrument

All 20
Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K802570.
AMPCO-DRESSING CHANGE TRAY-MAJOR DC
K802964 · Associated Medical Products Co. · Jan 1981
AMPCO-DRESSING CHANGE TRAY-MAJOR DC 7418
K802965 · Associated Medical Products Co. · Jan 1981
AUXILIARY TRAY
K802088 · American Pharmaseal Div. Ahsc · Nov 1980
CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI
K801964 · American Pharmaseal Div. Ahsc · Oct 1980
CUSTOM UNIVERSAL CUTDOWN PREP TRAY
K801965 · American Pharmaseal Div. Ahsc · Oct 1980
MICRO CLIP STERILIZING CASE #65199
K801470 · Edward Weck, Inc. · Jul 1980