Cleared Traditional

K935246 - ARBO H49P

K935246 is an FDA 510(k) clearance for ARBO H49P, manufactured by Arbo Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 380-day FDA review.

K935246 · Arbo Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
380d
Days
Class 2
Risk

K935246 is an FDA 510(k) clearance for the ARBO H49P, H59P DISPOSABLE MONITORING ELECTRODES. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Arbo Medical, Inc. (Stratford, US). The FDA issued a Cleared decision on November 16, 1994 after a review of 380 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - 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. Elevated predicate reliance profile. 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 Arbo Medical, Inc. devices

FDA 510(k) Submission Details - K935246

510(k) Number K935246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1993
Decision Date November 16, 1994
Days to Decision 380 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
255d slower than avg
Panel avg: 125d · This submission: 380d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 - DRX Electrode, Electrocardiograph

All 97
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K935246.
GRAPHIC CONTROLS Q-TRACE GOLD ECG ELECTRODE
K950487 · Graphic Controls Corp. · May 1995
EKG VEST
K932903 · Cardiotronics, Inc. · Feb 1995
QUIK COMBO
K943301 · Physio-Control Corp. · Feb 1995
MEDI-TRACE NEONATAL ECG ELECTRODE WITH PREATTACHED LEADWIRE
K945214 · Graphic Controls Corp. · Nov 1994
3M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE
K930312 · 3M Health Care, Ltd. · Sep 1993
3M RED DOT 2330 RESTING EKG ELECTRODE
K932454 · 3M Health Care, Ltd. · Aug 1993