510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963326Substantially Equivalent

Breathe Fit

Cambridge Assoc., Beverly MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963326 is the FDA 510(k) clearance record for BREATHE FIT, a class I device, cleared for Cambridge Assoc. on under FDA product code LWF (Dilator, Nasal). FDA records list one 510(k) clearance for Cambridge Assoc. As of , FDA records show no recalls naming K963326.

Clearance record

Decision date
Received
(173 days to decision)
Product code
LWF Dilator, Nasal
Regulation
21 CFR 874.3900
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Cambridge Assoc. 15 Oak St., Beverly MA
510(k) summary
Summary
Third party review
No

Clearances, product code LWF

Trailing 12 months

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

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