510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011125Substantially Equivalent

Nasal Cannula, with and without Supply Tubing, and Other Similar Nasal Cannula Manufactured by Hrci

Hudson Respiratory Care, Inc., Temecula CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011125 is the FDA 510(k) clearance record for NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI, a class I device, cleared for Hudson Respiratory Care, Inc. on under FDA product code CAT (Cannula, Nasal, Oxygen). FDA records list 15 510(k) clearances for Hudson Respiratory Care, Inc., from to . As of , FDA records show no recalls naming K011125.

Clearance record

Decision date
Received
(61 days to decision)
Product code
CAT Cannula, Nasal, Oxygen
Regulation
21 CFR 868.5340
Device class
Class I
Review panel
Anesthesiology
Applicant
Hudson Respiratory Care, Inc. 27711 Diaz Rd., Temecula CA
510(k) summary
Summary
Third party review
No

Clearances, product code CAT

Trailing 12 months

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

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