Cleared Traditional

K012636 - BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100

K012636 is an FDA 510(k) clearance for BPTRU AUTOMATED NON-INVASIVE BLOOD PRES..., manufactured by Vsm Technology, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K012636 · Vsm Technology, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
74d
Days
Class 2
Risk

K012636 is an FDA 510(k) clearance for the BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Vsm Technology, Inc. (Vancouver, B.C., CA). The FDA issued a Cleared decision on October 26, 2001 after a review of 74 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vsm Technology, Inc. devices

FDA 510(k) Submission Details - K012636

510(k) Number K012636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2001
Decision Date October 26, 2001
Days to Decision 74 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 125d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

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 846
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K012636.
ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS
K013539 · Rossmax International , Ltd. · Jan 2002
ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS
K013583 · Rossmax International , Ltd. · Jan 2002
HL168E
K014122 · Health & Life Co., Ltd. · Jan 2002
MODIFICATION TO: HL168W TOUCH SCREEN
K013033 · Health & Life Co., Ltd. · Oct 2001
MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR
K012310 · Health & Life Co., Ltd. · Aug 2001
ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS
K011352 · Rossmax International , Ltd. · Jul 2001