Cleared Special

BMT ANSCORE HEALTH MANAGEMENT SYSTEM (K010955) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K010955 · Boston Medical Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
27d
Days
Class 2
Risk

K010955 is an FDA 510(k) clearance for the BMT ANSCORE HEALTH MANAGEMENT SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Boston Medical Technologies, Inc. (Wakefield, US). The FDA issued a Cleared decision on April 26, 2001 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Medical Technologies, Inc. devices

Submission Details

510(k) Number K010955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2001
Decision Date April 26, 2001
Days to Decision 27 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 119
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K010955.
CARDIOFAX CE, MODEL ECG-1500 A
K052511 · Nihon Kohden America, Inc. · May 2006
CARDIOFAX CE, MODEL PEA-1110K
K042827 · Nihon Kohden America, Inc. · Jan 2005
PACEART SYSTEM
K024278 · Medtronic Vascular · May 2003
WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES
K002473 · Nihon Kohden America, Inc. · Nov 2000
QUINTON Q-STRESS, MODEL 000483
K001492 · Quinton, Inc. · Aug 2000
M1765A ECG MANAGER
K974746 · Hewlett-Packard Co. · Mar 1998