510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K101457Substantially Equivalent

Easyplus Mini R9n Self Monitoring Blood Glucose System Model Eps10031

Eps Bio Technology Corp., Hsinchu City, Hsinchu, TW / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K101457 is the FDA 510(k) clearance record for EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031, a class II device, cleared for Eps Bio Technology Corp. on under FDA product code NBW (System, Test, Blood Glucose, Over The Counter). FDA records list 24 510(k) clearances for Eps Bio Technology Corp., from to . As of , FDA records show no recalls naming K101457.

Clearance record

Decision date
Received
(36 days to decision)
Product code
NBW System, Test, Blood Glucose, Over The Counter
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Eps Bio Technology Corp. #8 R&D Rd. Iii, Hsinchu City, Hsinchu, TW
510(k) summary
Statement
Third party review
No

Clearances, product code NBW

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