510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895866Substantially Equivalent

Dird Ingant O2 (Bio 2 Hood)

Bird Products Corp., Palm Spring CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895866 is the FDA 510(k) clearance record for DIRD INGANT O2 (BIO 2 HOOD), a class I device, cleared for Bird Products Corp. on under FDA product code BYL (Tent, Oxygen). FDA records list 35 510(k) clearances for Bird Products Corp., from to . As of , FDA records show no recalls naming K895866.

Clearance record

Decision date
Received
(23 days to decision)
Product code
BYL Tent, Oxygen
Regulation
21 CFR 868.5700
Device class
Class I
Review panel
Anesthesiology
Applicant
Bird Products Corp. 1100 Bird Center Dr., Palm Spring CA
Third party review
No

Clearances, product code BYL

Trailing 12 months

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

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