510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915158Substantially Equivalent

Surebreath Dome, E-Z Breather

Ipax, Inc., Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915158 is the FDA 510(k) clearance record for SUREBREATH DOME, E-Z BREATHER, a class I device, cleared for Ipax, Inc. on under FDA product code GAD (Retractor). FDA records list 16 510(k) clearances for Ipax, Inc., from to . As of , FDA records show no recalls naming K915158.

Clearance record

Decision date
Received
(90 days to decision)
Product code
GAD Retractor
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Ipax, Inc. 2109 W. Amherst Ave., Englewood CO
510(k) summary
Statement
Third party review
No

Clearances, product code GAD

Trailing 12 months

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

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