510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K200401Substantially Equivalent

Apogee

Incoba Ltd D/B/A Dynaris, Chesterfield MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200401 is the FDA 510(k) clearance record for Apogee, a class II device, cleared for Incoba Ltd D/B/A Dynaris on under FDA product code NFB (Conserver, Oxygen). FDA records list one 510(k) clearance for Incoba Ltd D/B/A Dynaris. As of , FDA records show no recalls naming K200401.

Clearance record

Decision date
Received
(270 days to decision)
Product code
NFB Conserver, Oxygen
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
Incoba Ltd D/B/A Dynaris Spirit 40 Park Dr., Chesterfield MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NFB

Trailing 12 months

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

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