510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K091897Substantially Equivalent

Blood Pressure Monitor, Model Fora P11/td-3019

Taidoc Technology Corporation, New Taipei City, TW / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K091897 is the FDA 510(k) clearance record for BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019, 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 K091897.

Clearance record

Decision date
Received
(62 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 6f, # 127, Wugong 2nd Rd., New Taipei City, TW
510(k) summary
Statement
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