Cleared Traditional

K891075 - BARD NEONATAL ECG MONITORING ELECTRODE

K891075 is the FDA 510(k) clearance for BARD NEONATAL ECG MONITORING ELECTRODE by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K891075 · C.R. Bard, Inc. · Cardiovascular device
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Mar 1989
Decision
21d
Days
Class 2
Risk

K891075 is an FDA 510(k) clearance for the BARD NEONATAL ECG MONITORING ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tewksbury, US). The FDA issued a Cleared decision on March 22, 1989 after a review of 21 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K891075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1989
Decision Date March 22, 1989
Days to Decision 21 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 125d · This submission: 21d
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 80
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K891075.
BABY MAC ELECTROCARDIOGRAPH ELECTRODE
K895834 · Marquette Electronics, Inc. · Nov 1989
SELECTRODE
K894920 · S & W Medico Teknik · Oct 1989
F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM
K884980 · S & W Medico Teknik · May 1989
RADIOLUCENT ECG ELECTRODE MODEL NO: 1680
K890201 · Medtronic Vascular · Mar 1989
F40 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 40MM
K884981 · S & W Medico Teknik · Mar 1989
M68 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE,68
K884982 · S & W Medico Teknik · Mar 1989