510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K924654Substantially Equivalent

First Metatarsophalangeal Joint Motion Splint

Sutter Corp., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924654 is the FDA 510(k) clearance record for FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT, a class I device, cleared for Sutter Corp. on under FDA product code BXB (Exerciser, Powered). FDA records list 7 510(k) clearances for Sutter Corp., from to . As of , FDA records show no recalls naming K924654.

Clearance record

Decision date
Received
(160 days to decision)
Product code
BXB Exerciser, Powered
Regulation
21 CFR 890.5380
Device class
Class I
Review panel
Physical Medicine
Applicant
Sutter Corp. 9425 Chesapeake Dr., San Diego CA
510(k) summary
Statement
Third party review
No

Clearances, product code BXB

Trailing 12 months

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

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