510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915564Substantially Equivalent

Spiros

Life Support Products, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915564 is the FDA 510(k) clearance record for SPIROS, a class II device, cleared for Life Support Products, Inc. on under FDA product code BTL (Ventilator, Emergency, Powered (Resuscitator)). FDA records list 20 510(k) clearances for Life Support Products, Inc., from to . As of , FDA records show no recalls naming K915564.

Clearance record

Decision date
Received
(49 days to decision)
Product code
BTL Ventilator, Emergency, Powered (Resuscitator)
Regulation
21 CFR 868.5925
Device class
Class II
Review panel
Anesthesiology
Applicant
Life Support Products, Inc. One Mauchly, Irvine CA
510(k) summary
Statement
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