510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921355Substantially Equivalent

Wingmaster

Innovators, Inc., Jefferson City MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921355 is the FDA 510(k) clearance record for WINGMASTER, a class I device, cleared for Innovators, Inc. on under FDA product code EHB (Collimator, X-Ray). FDA records list 6 510(k) clearances for Innovators, Inc., from to . As of , FDA records show no recalls naming K921355.

Clearance record

Decision date
Received
(189 days to decision)
Product code
EHB Collimator, X-Ray
Regulation
21 CFR 872.1840
Device class
Class I
Review panel
Dental
Applicant
Innovators, Inc. 2721 D Industrial Dr., Jefferson City MO
510(k) summary
Statement
Third party review
No

Clearances, product code EHB

Trailing 12 months

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

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