510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896608Substantially Equivalent

Spag Pak

Viratek, Inc., Costa Mesa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896608 is the FDA 510(k) clearance record for SPAG PAK, a class I device, cleared for Viratek, Inc. on under FDA product code BYL (Tent, Oxygen). FDA records list 5 510(k) clearances for Viratek, Inc., from to . As of , FDA records show no recalls naming K896608.

Clearance record

Decision date
Received
(139 days to decision)
Product code
BYL Tent, Oxygen
Regulation
21 CFR 868.5700
Device class
Class I
Review panel
Anesthesiology
Applicant
Viratek, Inc. Icn Plz., Costa Mesa CA
Third party review
No

Clearances, product code BYL

Trailing 12 months

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

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