Cleared Special

SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE

K141113 · Spacelabs Healthcare, Ltd. · Cardiovascular
Sep 2014
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K141113 is an FDA 510(k) clearance for the SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE, a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Spacelabs Healthcare, Ltd. (Nederland, US). The FDA issued a Cleared decision on September 26, 2014, 149 days after receiving the submission on April 30, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K141113 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2014
Decision Date September 26, 2014
Days to Decision 149 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXN — System, Measurement, Blood-pressure, Non-invasive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1130

Similar Devices — DXN System, Measurement, Blood-pressure, Non-invasive

All 1203
YUWELL? Electronic Blood Pressure Monitor (YE630CR)
K252779 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Mar 2026
YUWELL? Electronic Blood Pressure Monitor (YE650AR)
K253228 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Feb 2026
Wrist Blood Pressure Monitor (BPM-W1VL)
K253133 · Shenzhen Imdk Medical Technology Co., Ltd. · Feb 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)
K252685 · Joytech Healthcare Co. , Ltd. · Feb 2026
Wearable Ambulatory Blood Pressure Monitor (WBP-02A)
K251581 · Shenzhen Hingmed Medical Instrument Co., Ltd. · Feb 2026
Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)
K251307 · Shenzhen Hingmed Medical Instrument Co., Ltd. · Jan 2026