510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K101054Substantially Equivalent

Romiapex Model a-15

Romidan, Ltd., Kiryat-Ono, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101054 is the FDA 510(k) clearance record for ROMIAPEX MODEL A-15, cleared for Romidan, Ltd. on under FDA product code LQY (Locator, Root Apex). FDA records list one 510(k) clearance for Romidan, Ltd. As of , FDA records show no recalls naming K101054.

Clearance record

Decision date
Received
(141 days to decision)
Product code
LQY Locator, Root Apex
Device class
Unclassified
Review panel
Unknown
Applicant
Romidan, Ltd. 5 Simcha Holzberg St., Kiryat-Ono, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LQY

Trailing 12 months
1 clearance under product code LQY in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LQY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260