510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001095Substantially Equivalent

Oxygen Sensors, Models Cir, C2r, R13, R15, Ri7med, R22med, R23, R24med, R29med, T1, T2,t4, T7 & Ufo130

Teledyne Analytical Instruments, City Of Industry CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001095 is the FDA 510(k) clearance record for OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130, a class II device, cleared for Teledyne Analytical Instruments on under FDA product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase). FDA records list 3 510(k) clearances for Teledyne Analytical Instruments, from to . As of , FDA records show one recall naming K001095.

Clearance record

Decision date
Received
(87 days to decision)
Product code
CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Regulation
21 CFR 868.1720
Device class
Class II
Review panel
Anesthesiology
Applicant
Teledyne Analytical Instruments 16830 Chestnut St., City Of Industry CA
510(k) summary
Statement
Third party review
No

Clearances, product code CCL

Trailing 12 months
1 clearance under product code CCL in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CCL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260