510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K100658Substantially Equivalent

U-Right Td-3127 Blood Pressure Monitoring System

Taidoc Technology Corporation, Taipei County, TW / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100658 is the FDA 510(k) clearance record for U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM, a class II device, cleared for Taidoc Technology Corporation on under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive). FDA records list 123 510(k) clearances for Taidoc Technology Corporation, from to . As of , FDA records show no recalls naming K100658.

Clearance record

Decision date
Received
(123 days to decision)
Product code
DXN System, Measurement, Blood-Pressure, Non-Invasive
Regulation
21 CFR 870.1130
Device class
Class II
Review panel
Cardiovascular
Applicant
Taidoc Technology Corporation 3f, 5f, No 127 Wugong 2nd Rd., Taipei County, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXN

Trailing 12 months
30 clearances under product code DXN in the twelve months to November 2026, April 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DXN, trailing twelve months
MonthClearances
December 20251
January 20262
February 20264
March 20262
April 20265
May 20263
June 20264
July 20262
August 20264
September 20262
October 20261
November 20260