Cleared Traditional

K100310 - BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS

K100310 is an FDA 510(k) clearance for BTL-08 ECG RECORDER MODEL BTL-08 ECG LC..., manufactured by BTL Industries, Inc.. The device is a Class 2 Cardiovascular device with product code MWJ cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K100310 · BTL Industries, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2010
Decision
252d
Days
Class 2
Risk

K100310 is an FDA 510(k) clearance for the BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by BTL Industries, Inc. (Austin, US). The FDA issued a Cleared decision on October 13, 2010 after a review of 252 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 BTL Industries, Inc. devices

FDA 510(k) Submission Details - K100310

510(k) Number K100310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2010
Decision Date October 13, 2010
Days to Decision 252 days
Submission Type Traditional
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
127d slower than avg
Panel avg: 125d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWJ Device Classification - Class 2, Special Controls

Product Code MWJ Electrocardiograph, Ambulatory (without Analysis)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - MWJ Electrocardiograph, Ambulatory (without Analysis)

All 32
Devices cleared under the same product code (MWJ) and FDA review panel - the closest regulatory comparables to K100310.
CARDIOMEM
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HOLTER RECORDER H3+
K043010 · Mortara Instrument, Inc. · Feb 2005
SPIDERVIEW
K032466 · Ela Medical, Inc. · Aug 2003