Cleared Traditional

BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1 (K991831) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 K991831.
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NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH
K972310 · Nihon Kohden America, Inc. · Aug 1997
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K964784 · Quinton, Inc. · Aug 1997