510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854241Substantially Equivalent

Aot External Compress Device

Advanced Ortho-Technology, Inc., Tuckahoe NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854241 is the FDA 510(k) clearance record for AOT EXTERNAL COMPRESS DEVICE, a class I device, cleared for Advanced Ortho-Technology, Inc. on under FDA product code HWN (Instrument, Compression). FDA records list 3 510(k) clearances for Advanced Ortho-Technology, Inc., from to . As of , FDA records show no recalls naming K854241.

Clearance record

Decision date
Received
(133 days to decision)
Product code
HWN Instrument, Compression
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Advanced Ortho-Technology, Inc. 150 Marbledale Rd., Tuckahoe NY
Third party review
No

Clearances, product code HWN

Trailing 12 months

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

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