510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912747Substantially Equivalent

Lulmitex Neonatal Transilluminator

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

K912747 is the FDA 510(k) clearance record for LULMITEX NEONATAL TRANSILLUMINATOR, a class I device, cleared for Lumitex, Inc. on under FDA product code HJN (Transilluminator, Battery-Powered). FDA records list 3 510(k) clearances for Lumitex Medical Devices, Inc., from to . As of , FDA records show no recalls naming K912747.

Clearance record

Decision date
Received
(186 days to decision)
Product code
HJN Transilluminator, Battery-Powered
Regulation
21 CFR 886.1945
Device class
Class I
Review panel
Ophthalmic
Applicant
Lumitex, Inc. 11941 Abbey Rd., Bldg. H, Cleveland OH
510(k) summary
Statement
Third party review
No

Clearances, product code HJN

Trailing 12 months

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

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