Cleared Traditional

K993875 - BMT ANSCORE HEALTH MANAGEMENT SYSTEM

K993875 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 270-day FDA review.

K993875 · Boston Medical Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Aug 2000
Decision
270d
Days
Class 2
Risk

K993875 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 August 11, 2000 after a review of 270 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K993875

510(k) Number K993875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1999
Decision Date August 11, 2000
Days to Decision 270 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 125d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K993875.
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K020708 · Philips Medical Systems, Inc. · Apr 2002
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K002459 · Agilent Technologies, Inc. · Nov 2000
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
GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11
K000645 · General Electric Medical Systems Information Techn · May 2000
MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION
K991786 · General Electric Medical Systems Information Techn · Nov 1999