510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843522Substantially Equivalent

Donway Splint

Australian Biomedical Corporation, Ltd., Australia / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843522 is the FDA 510(k) clearance record for DONWAY SPLINT, a class II device, cleared for Australian Biomedical Corporation , Ltd. on under FDA product code ITH (Equipment, Traction, Powered). FDA records list 5 510(k) clearances for Australian Biomedical Corporation , Ltd., from to . As of , FDA records show no recalls naming K843522.

Clearance record

Decision date
Received
(153 days to decision)
Product code
ITH Equipment, Traction, Powered
Regulation
21 CFR 890.5900
Device class
Class II
Review panel
Physical Medicine
Applicant
Australian Biomedical Corporation , Ltd. 447-459 Willianstown Rd., Australia
Third party review
No

Clearances, product code ITH

Trailing 12 months

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

FDA records show no clearances under product code ITH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ITH, 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