510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915067Substantially Equivalent

Disposable Needle Counters & Disposable Systems

American Medical Corp., Woodland Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915067 is the FDA 510(k) clearance record for DISPOSABLE NEEDLE COUNTERS & DISPOSABLE SYSTEMS, a class II device, cleared for American Medical Corp. on under FDA product code MMK (Container, Sharps). FDA records list 3 510(k) clearances for American Medical Corp., from to . As of , FDA records show no recalls naming K915067.

Clearance record

Decision date
Received
(124 days to decision)
Product code
MMK Container, Sharps
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
American Medical Corp. 22231 Mulholland Hwy., Woodland Hills CA
510(k) summary
Statement
Third party review
No

Clearances, product code MMK

Trailing 12 months
3 clearances under product code MMK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MMK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20261
September 20260
October 20260