510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063666Substantially Equivalent

Sharps Container, Model 039-413

Sport Medical Technology Inc, Shirley NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063666 is the FDA 510(k) clearance record for SHARPS CONTAINER, MODEL 039-413, a class II device, cleared for Biodex Medical Systems, Inc. on under FDA product code MMK (Container, Sharps). FDA records list 9 510(k) clearances for Sport Medical Technology Inc, from to . As of , FDA records show no recalls naming K063666.

Clearance record

Decision date
Received
(45 days to decision)
Product code
MMK Container, Sharps
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Biodex Medical Systems, Inc. 20 Ramsay Rd., Shirley NY
510(k) summary
Summary PDF
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