Cleared Traditional

K182934 - FORA P100 Blood Pressure Monitoring System

K182934 is the FDA 510(k) clearance for FORA P100 Blood Pressure Monitoring System by Taidoc Technology Corporation. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K182934 · Taidoc Technology Corporation · Cardiovascular device
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Feb 2019
Decision
113d
Days
Class 2
Risk

K182934 is an FDA 510(k) clearance for the FORA P100 Blood Pressure Monitoring System. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on February 12, 2019 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Taidoc Technology Corporation devices

Submission Details

510(k) Number K182934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2018
Decision Date February 12, 2019
Days to Decision 113 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 125d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 501
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K182934.
Microlife Digital Blood Pressure Monitor
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K182481 · Omron Healthcare, Inc. · Nov 2018