510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K050314Substantially Equivalent

Aquinox

Abbott Medical, Wampsville NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050314 is the FDA 510(k) clearance record for AQUINOX, a class II device, cleared for Smiths Medical Asd, Inc. on under FDA product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K050314.

Clearance record

Decision date
Received
(9 days to decision)
Product code
BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Regulation
21 CFR 868.5450
Device class
Class II
Review panel
Anesthesiology
Applicant
Smiths Medical Asd, Inc. One Madison St., Wampsville NY
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code BTT

Trailing 12 months
5 clearances under product code BTT in the twelve months to November 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BTT, trailing twelve months
MonthClearances
December 20251
January 20262
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260
November 20260