510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954194Substantially Equivalent

Disposable Hme/filter

Engstrom Medical, Sturgis MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954194 is the FDA 510(k) clearance record for DISPOSABLE HME/FILTER, a class I device, cleared for Engstrom Medical on under FDA product code BYD (Condenser, Heat And Moisture (Artificial Nose)). FDA records list 2 510(k) clearances for Engstrom Medical, from to . As of , FDA records show no recalls naming K954194.

Clearance record

Decision date
Received
(44 days to decision)
Product code
BYD Condenser, Heat And Moisture (Artificial Nose)
Regulation
21 CFR 868.5375
Device class
Class I
Review panel
Anesthesiology
Applicant
Engstrom Medical 67920 Klinger Lake Rd., Sturgis MI
510(k) summary
Summary
Third party review
No

Clearances, product code BYD

Trailing 12 months

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

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