Cleared Traditional

K991831 - BMT ANSCORE HEALTH MANAGEMENT SYSTEM

K991831 is an FDA 510(k) clearance for BMT ANSCORE HEALTH MANAGEMENT SYSTEM, manufactured by Boston Medical Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K991831 · Boston Medical Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
14d
Days
Class 2
Risk

K991831 is an FDA 510(k) clearance for the BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1. 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 June 11, 1999 after a review of 14 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. 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 Boston Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K991831

510(k) Number K991831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1999
Decision Date June 11, 1999
Days to Decision 14 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DPS Device Classification - Class 2, Special Controls

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 283
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K991831.
QUINTON Q-STRESS, MODEL 000483
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K974746 · Hewlett-Packard Co. · Mar 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100
K972746 · Alexander Mfg. Co. · Oct 1997
SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS
K972199 · Marquette Electronics, Inc. · Sep 1997