Cleared Special

K012540 - BLY-501 ADAPTOR

K012540 is an FDA 510(k) clearance for BLY-501 ADAPTOR, manufactured by Micromedical Industries, Ltd.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Special 510(k) pathway after a 50-day FDA review.

K012540 · Micromedical Industries, Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
50d
Days
Class 2
Risk

K012540 is an FDA 510(k) clearance for the BLY-501 ADAPTOR. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Micromedical Industries, Ltd. (Labrador, Queensland, AU). The FDA issued a Cleared decision on September 26, 2001 after a review of 50 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.

FDA 510(k) Submission Details - K012540

510(k) Number K012540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2001
Decision Date September 26, 2001
Days to Decision 50 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 125d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

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 571
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K012540.
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
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K012263 · National Custom Ent., Inc. · Oct 2001
MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC
K012264 · National Custom Ent., Inc. · Oct 2001
MOBILE-PATIENT VIEWER
K011436 · Data Critical Corporation · Jul 2001
BCI ADVISOR VITAL SIGNS MONITOR (9200)
K011177 · Bci, Inc. · May 2001
BMT ANSCORE HEALTH MANAGEMENT SYSTEM
K010955 · Boston Medical Technologies, Inc. · Apr 2001
K012540 · BLY-501 ADAPTOR
Download PDF FDA Summary Micromedical Industri…