510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955105Substantially Equivalent

Bte Cpm-10

Baltimore Therapeutic Equipment Co., Hanover MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955105 is the FDA 510(k) clearance record for BTE CPM-10, a class I device, cleared for Baltimore Therapeutic Equipment Co. on under FDA product code BXB (Exerciser, Powered). FDA records list 7 510(k) clearances for Baltimore Therapeutic Equipment Co., from to . As of , FDA records show no recalls naming K955105.

Clearance record

Decision date
Received
(51 days to decision)
Product code
BXB Exerciser, Powered
Regulation
21 CFR 890.5380
Device class
Class I
Review panel
Physical Medicine
Applicant
Baltimore Therapeutic Equipment Co. 7455-L New Ridge Rd., Hanover MD
510(k) summary
Summary
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