510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884521Substantially Equivalent

Star Sync

Infrasonics Corp., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884521 is the FDA 510(k) clearance record for STAR SYNC, a class II device, cleared for Infrasonics Corp. on under FDA product code CBK (Ventilator, Continuous, Facility Use). FDA records list 20 510(k) clearances for Infrasonics Corp., from to . As of , FDA records show no recalls naming K884521.

Clearance record

Decision date
Received
(224 days to decision)
Product code
CBK Ventilator, Continuous, Facility Use
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Infrasonics Corp. 9944 Barnes Canyon Rd., San Diego CA
Third party review
No

Clearances, product code CBK

Trailing 12 months
4 clearances under product code CBK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CBK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260