510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914615Substantially Equivalent

Btp(tm) Centraline(tm) Suit

Btp Industries, Inc., S. Hamilton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914615 is the FDA 510(k) clearance record for BTP(TM) CENTRALINE(TM) SUIT, a class I device, cleared for Btp Industries, Inc. on under FDA product code FXO (Suit, Surgical). FDA records list one 510(k) clearance for Btp Industries, Inc. As of , FDA records show no recalls naming K914615.

Clearance record

Decision date
Received
(201 days to decision)
Product code
FXO Suit, Surgical
Regulation
21 CFR 878.4040
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Btp Industries, Inc. P.O. Box 2357, S. Hamilton MA
510(k) summary
Statement
Third party review
No

Clearances, product code FXO

Trailing 12 months

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

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