510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081335Substantially Equivalent

Tenacore Oxygen Blender, Model Tb-2000

Tenacore Holdings, Inc., Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081335 is the FDA 510(k) clearance record for TENACORE OXYGEN BLENDER, MODEL TB-2000, a class II device, cleared for Tenacore Holdings, Inc. on under FDA product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation). FDA records list 4 510(k) clearances for Tenacore Holdings, Inc., from to . As of , FDA records show no recalls naming K081335.

Clearance record

Decision date
Received
(186 days to decision)
Product code
BZR Mixer, Breathing Gases, Anesthesia Inhalation
Regulation
21 CFR 868.5330
Device class
Class II
Review panel
Anesthesiology
Applicant
Tenacore Holdings, Inc. 647 E. Young St., Santa Ana CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZR

Trailing 12 months

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

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