510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221349Substantially Equivalent

XPER Technology PREMIUM Pro Blood Glucose Monitoring System

Taidoc Technology Corporation, New Taipei City, TW / Dual Track, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221349 is the FDA 510(k) clearance record for XPER Technology PREMIUM Pro Blood Glucose Monitoring System, a class II device, cleared for Taidoc Technology Corporation on under FDA product code PZI (Prescription Use Blood Glucose Meter For Near-Patient Testing). FDA's definition for product code PZI reads: "Intended for use in near-patient testing settings for in vitro diagnostic, multiple-patient use for the quantitative determination of glucose throughout all hospital and all professional healthcare settings for use in determining...". FDA records list 123 510(k) clearances for Taidoc Technology Corporation, from to . As of , FDA records show no recalls naming K221349.

Clearance record

Decision date
Received
(925 days to decision)
Product code
PZI Prescription Use Blood Glucose Meter For Near-Patient Testing
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Taidoc Technology Corporation B1-7f, #127, Wugong 2nd Rd., New Taipei City, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PZI

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