510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K902604Substantially Equivalent

Blake Medical Breathing Tube Support

Blake Medical, Inc., Tifton GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902604 is the FDA 510(k) clearance record for BLAKE MEDICAL BREATHING TUBE SUPPORT, a class I device, cleared for Blake Medical, Inc. on under FDA product code CBH (Device, Fixation, Tracheal Tube). FDA records list 2 510(k) clearances for Blake Medical, Inc., from to . As of , FDA records show no recalls naming K902604.

Clearance record

Decision date
Received
(112 days to decision)
Product code
CBH Device, Fixation, Tracheal Tube
Regulation
21 CFR 868.5770
Device class
Class I
Review panel
Anesthesiology
Applicant
Blake Medical, Inc. 2803 Carmicheal Dr., Tifton GA
Third party review
No

Clearances, product code CBH

Trailing 12 months

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

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