510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915846Substantially Equivalent

Biodex System 2 Autoprogram

Biodex Corp., Shirley NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915846 is the FDA 510(k) clearance record for BIODEX SYSTEM 2 AUTOPROGRAM, a class II device, cleared for Biodex Corp. on under FDA product code IKK (System, Isokinetic Testing And Evaluation). FDA records list 7 510(k) clearances for Biodex Corp., from to . As of , FDA records show no recalls naming K915846.

Clearance record

Decision date
Received
(31 days to decision)
Product code
IKK System, Isokinetic Testing And Evaluation
Regulation
21 CFR 890.1925
Device class
Class II
Review panel
Physical Medicine
Applicant
Biodex Corp. 20 Ramsay Rd., Shirley NY
510(k) summary
Summary
Third party review
No

Clearances, product code IKK

Trailing 12 months

FDA records hold no clearances under product code IKK in the trailing twelve months.

FDA records show no clearances under product code IKK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IKK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260