Cleared Traditional

Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC (K243545) - FDA 510(k) Clearance

Also marketed or referenced as:
989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m M1663A,10 Lead ECG Trunk AAMI/IEC 2m M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m M1671A, 3 Leadset, Grabber, AAMI, ICU M1673A, 3 Leadset, Sn

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

K243545 · Philips Medizin Systeme B?blingen GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
63d
Days
Class 2
Risk

K243545 is an FDA 510(k) clearance for the Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 98.... Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Philips Medizin Systeme B?blingen GmbH (Böblingen, DE). The FDA issued a Cleared decision on January 17, 2025 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2900 - 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 Philips Medizin Systeme B?blingen GmbH devices

Submission Details

510(k) Number K243545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2024
Decision Date January 17, 2025
Days to Decision 63 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
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSA Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2900
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 - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 40
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