510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982225Substantially Equivalent

Spiracle Technology-Bi-Flow Demand/resuscitator Valve, Model 504

Spiracle Technology, Fountain Valley CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982225 is the FDA 510(k) clearance record for SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504, a class II device, cleared for Spiracle Technology on under FDA product code BTL (Ventilator, Emergency, Powered (Resuscitator)). FDA records list 4 510(k) clearances for Spiracle Technology, from to . As of , FDA records show no recalls naming K982225.

Clearance record

Decision date
Received
(126 days to decision)
Product code
BTL Ventilator, Emergency, Powered (Resuscitator)
Regulation
21 CFR 868.5925
Device class
Class II
Review panel
Anesthesiology
Applicant
Spiracle Technology 16520 Harbor Blvd., Unit D, Fountain Valley CA
510(k) summary
Summary
Third party review
No

Clearances, product code BTL

Trailing 12 months

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

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