Cleared Traditional

ARBO PINK H82P (K884775) - FDA 510(k) Clearance

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

K884775 · Arbo Medical, Inc. · Cardiovascular device
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Feb 1989
Decision
82d
Days
Class 2
Risk

K884775 is an FDA 510(k) clearance for the ARBO PINK H82P. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Arbo Medical, Inc. (Wilton, US). The FDA issued a Cleared decision on February 6, 1989 after a review of 82 days - a notably fast clearance cycle.

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: 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 Arbo Medical, Inc. devices

Submission Details

510(k) Number K884775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1988
Decision Date February 06, 1989
Days to Decision 82 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 125d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 19
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K884775.
RED DOT CARDIAC SENSOR SYSTEM
K896155 · 3M Company · Dec 1989
BARD NEONATAL ECG MONITORING ELECTRODE
K891075 · C.R. Bard, Inc. · Mar 1989
RADIOLUCENT ECG ELECTRODE MODEL NO: 1680
K890201 · Medtronic Vascular · Mar 1989
BARD TAB ECG MONITORING ELECTRODE
K890103 · C.R. Bard, Inc. · Jan 1989
BARD MULTI-TAC ECG MONITORING ELECTRODE
K884064 · C.R. Bard, Inc. · Oct 1988
PRE-GELLED DISPOSABLE ECG ELECTRODE - HP13941A
K874421 · Hewlett-Packard Co. · Jan 1988