510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844160Substantially Equivalent

Ventibox

Syncor Intl. Corp., Sylmar CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844160 is the FDA 510(k) clearance record for VENTIBOX, a class I device, cleared for Syncor Intl. Corp. on under FDA product code KPY (Shield, Protective, Personnel). FDA records list 31 510(k) clearances for Syncor Intl. Corp., from to . As of , FDA records show no recalls naming K844160.

Clearance record

Decision date
Received
(54 days to decision)
Product code
KPY Shield, Protective, Personnel
Regulation
21 CFR 892.6500
Device class
Class I
Review panel
Radiology
Applicant
Syncor Intl. Corp. 12847 Arroyo St., Sylmar CA
Third party review
No

Clearances, product code KPY

Trailing 12 months

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

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