510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K955520Substantially Equivalent

Rescue Breather

International Safety, Inc., Eugene OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955520 is the FDA 510(k) clearance record for RESCUE BREATHER, a class II device, cleared for International Safety, Inc. on under FDA product code CBP (Valve, Non-Rebreathing). FDA records list one 510(k) clearance for International Safety, Inc. As of , FDA records show no recalls naming K955520.

Clearance record

Decision date
Received
(309 days to decision)
Product code
CBP Valve, Non-Rebreathing
Regulation
21 CFR 868.5870
Device class
Class II
Review panel
Anesthesiology
Applicant
International Safety, Inc. 2322 Douglas Dr., Eugene OR
510(k) summary
Summary
Third party review
No

Clearances, product code CBP

Trailing 12 months

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

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