510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K223367Substantially Equivalent

Ochsner Connected Inhaler Sensor

Ochsner Clinic Foundation, New Orleans LA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223367 is the FDA 510(k) clearance record for Ochsner Connected Inhaler Sensor, a class II device, cleared for Ochsner Clinic Foundation on under FDA product code CAF (Nebulizer (Direct Patient Interface)). FDA records list one 510(k) clearance for Ochsner Clinic Foundation. As of , FDA records show no recalls naming K223367.

Clearance record

Decision date
Received
(299 days to decision)
Product code
CAF Nebulizer (Direct Patient Interface)
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Applicant
Ochsner Clinic Foundation 1514 Jefferson Hwy., New Orleans LA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CAF

Trailing 12 months
4 clearances under product code CAF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CAF, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260