Cleared Traditional

K885262 - POLYHESIVE MONITORING AND DIAGNOSTIC EL...

K885262 is an FDA 510(k) clearance for POLYHESIVE MONITORING AND DIAGNOSTIC EL..., manufactured by Valleylab, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K885262 · Valleylab, Inc. · Cardiovascular device
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Jan 1989
Decision
33d
Days
Class 2
Risk

K885262 is an FDA 510(k) clearance for the POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Valleylab, Inc. (Boulder, US). The FDA issued a Cleared decision on January 25, 1989 after a review of 33 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 Valleylab, Inc. devices

FDA 510(k) Submission Details - K885262

510(k) Number K885262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1988
Decision Date January 25, 1989
Days to Decision 33 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
92d faster than avg
Panel avg: 125d · This submission: 33d
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 89
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K885262.
M68 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE,68
K884982 · S & W Medico Teknik · Mar 1989
M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55
K884983 · S & W Medico Teknik · Mar 1989
M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40
K884984 · S & W Medico Teknik · 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