510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934549Substantially Equivalent

All-Vue Ultra-Lite Thin Wall Syringe Shield

Victoreen, Inc., Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934549 is the FDA 510(k) clearance record for ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD, a class I device, cleared for Victoreen, Inc. on under FDA product code IWR (Holder, Syringe, Lead). FDA records list 40 510(k) clearances for Victoreen, Inc., from to . As of , FDA records show no recalls naming K934549.

Clearance record

Decision date
Received
(150 days to decision)
Product code
IWR Holder, Syringe, Lead
Regulation
21 CFR 892.6500
Device class
Class I
Review panel
Radiology
Applicant
Victoreen, Inc. 6000 Cochran Rd., Cleveland OH
510(k) summary
Statement
Third party review
No

Clearances, product code IWR

Trailing 12 months

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

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