510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896949Substantially Equivalent

Mobile X-Ray Personnel Protective Screens

Innovative Products Mfg., East Haven CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896949 is the FDA 510(k) clearance record for MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS, a class I device, cleared for Innovative Products Mfg. on under FDA product code EAK (Screen, Leaded, Operator Radiation Protector). FDA records list one 510(k) clearance for Innovative Products Mfg. As of , FDA records show no recalls naming K896949.

Clearance record

Decision date
Received
(65 days to decision)
Product code
EAK Screen, Leaded, Operator Radiation Protector
Regulation
21 CFR 892.6500
Device class
Class I
Review panel
Radiology
Applicant
Innovative Products Mfg. Box 447, East Haven CT
Third party review
No

Clearances, product code EAK

Trailing 12 months

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

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