Cleared Traditional

K872871 - NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR)

K872871 is an FDA 510(k) clearance for NEONATAL SPUNLACE BREATHABLE POLY. FABR..., manufactured by Labeltape Meditect, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K872871 · Labeltape Meditect, Inc. · Cardiovascular device
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Oct 1987
Decision
87d
Days
Class 2
Risk

K872871 is an FDA 510(k) clearance for the NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR). Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Labeltape Meditect, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on October 16, 1987 after a review of 87 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.

FDA 510(k) Submission Details - K872871

510(k) Number K872871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1987
Decision Date October 16, 1987
Days to Decision 87 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
38d faster than avg
Panel avg: 125d · This submission: 87d
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 328
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K872871.
FERRIS ECG ELECTRODE W/HYDROGEL
K873682 · Ferris Mfg. Corp. · Dec 1987
RESUBMITTED STANDARD MICROPORE ECG ELECTRODE
K874628 · Labeltape Meditect, Inc. · Dec 1987
ECG ELECTRODE SYSTEM
K873442 · Hiltrode, Inc.(A/S) Subsidiary Munkenes A/S · Nov 1987
MACTRODE-II
K872784 · Marquette Electronics, Inc. · Oct 1987
ELECTRODE RTE-3, CLIP-ON DIAGNOSTIC ELECTRODE
K871441 · Nitto Denko America, Inc. · Aug 1987
BIODAN TYPE COMET ELECTRODE
K871668 · National Medical Technology · Jun 1987
K872871 · NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR)
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