510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864095Substantially Equivalent

Engstrom Edith Models 500,1000,1500 & 1500F

Gambro, Inc., Lincolnshire IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864095 is the FDA 510(k) clearance record for ENGSTROM EDITH MODELS 500,1000,1500 & 1500F, a class I device, cleared for Gambro, Inc. on under FDA product code BYD (Condenser, Heat And Moisture (Artificial Nose)). FDA records list 87 510(k) clearances for Gambro, Inc., from to . As of , FDA records show no recalls naming K864095.

Clearance record

Decision date
Received
(122 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
Gambro, Inc. 600 Knightsbridge Pkwy., Lincolnshire IL
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