Cleared Traditional

A&D Medical UM-212BLE Blood Pressure Monitor (K212168) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212168 · A&D Company, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
451d
Days
Class 2
Risk

K212168 is an FDA 510(k) clearance for the A&D Medical UM-212BLE Blood Pressure Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by A&D Company, Ltd. (San Jose, US). The FDA issued a Cleared decision on October 6, 2022 after a review of 451 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all A&D Company, Ltd. devices

Submission Details

510(k) Number K212168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2021
Decision Date October 06, 2022
Days to Decision 451 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
326d slower than avg
Panel avg: 125d · This submission: 451d
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 281
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K212168.
YUWELL Electronic Blood Pressure Monitor
K221372 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Oct 2022
Arm Blood Pressure Monitor
K221913 · Alicn Medical (Shenzhen), Inc. · Oct 2022
InBody Blood pressure monitor, Model BPBIO480KV
K221764 · Inbody Co., Ltd. · Oct 2022
Electronic Sphygmomanometer (Model: LT-P30)
K220220 · Zhuhai Linte Medical Instrument Co., Ltd. · Oct 2022
Blood Pressure Monitor(Model:Y30001)
K213023 · Zhangzhou Easepal Medical Science and Technology Co., Ltd. · Sep 2022
Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11)
K221040 · Jiangxi Aicare Medical Technology Co., Ltd. · Aug 2022