510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233337Substantially Equivalent

Freespira Breathing System

Freespira, Inc, Kirkland WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K233337 is the FDA 510(k) clearance record for Freespira Breathing System, a class II device, cleared for Freespira, Inc. on under FDA product code SEN (Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety). FDA's definition for product code SEN reads: "A biofeedback device for adjunctive treatment of patient-reported symptoms associated with stress and anxiety is intended to provide feedback to users with patient-reported symptoms associated with stress and anxiety on a physiological...". FDA records list one 510(k) clearance for Freespira, Inc. As of , FDA records show no recalls naming K233337.

Clearance record

Decision date
Received
(573 days to decision)
Product code
SEN Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety
Regulation
21 CFR 882.5050
Device class
Class II
Review panel
Neurology
Applicant
Freespira, Inc. 12020 113th Ave. NE, Suite 215, Kirkland WA
Third party review
No

Clearances, product code SEN

Trailing 12 months

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

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