510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854537Substantially Equivalent

Headstrap

Life Design Systems, Inc., Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854537 is the FDA 510(k) clearance record for HEADSTRAP, a class I device, cleared for Life Design Systems, Inc. on under FDA product code BTK (Strap, Head, Gas Mask). FDA records list 29 510(k) clearances for Life Design Systems, Inc., from to . As of , FDA records show no recalls naming K854537.

Clearance record

Decision date
Received
(20 days to decision)
Product code
BTK Strap, Head, Gas Mask
Regulation
21 CFR 868.5560
Device class
Class I
Review panel
Anesthesiology
Applicant
Life Design Systems, Inc. 11017 W. Layton Ave., Milwaukee WI
Third party review
No

Clearances, product code BTK

Trailing 12 months

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

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