Cleared Traditional

K823361 - SWITCHING UNIT ELECTRODE CATHETERS

K823361 is an FDA 510(k) clearance for SWITCHING UNIT ELECTRODE CATHETERS, manufactured by Webster Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K823361 · Webster Laboratories, Inc. · Cardiovascular device
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Jan 1983
Decision
66d
Days
Class 2
Risk

K823361 is an FDA 510(k) clearance for the SWITCHING UNIT ELECTRODE CATHETERS. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Webster Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on January 14, 1983 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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 Webster Laboratories, Inc. devices

FDA 510(k) Submission Details - K823361

510(k) Number K823361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1982
Decision Date January 14, 1983
Days to Decision 66 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 125d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRF Device Classification - Class 2, Special Controls

Product Code DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
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 - DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

All 151
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K823361.
BARD EPICARDIAL ELECTRODE ARRAY
K872231 · C.R. Bard, Inc. · Oct 1987
ELECATH GALLAGHER MAPPING CATHETER
K844805 · Electro-Catheter Corp. · Jan 1985
MODEL TP THERMISTOR PROBE
K831528 · Scimed Life Systems, Inc. · Jun 1983
MIKRO-TIP CATHETER PRESSURE TRANSDUCER
K823434 · Millar Instruments, Inc. · Nov 1982
MILLAR MIKRO-TIP CATHETER PRESSURE TRAN.
K812944 · Millar Instruments, Inc. · Nov 1981
MAPPING PROBE MODEL #6540
K802058 · Cardiac Pacemakers, Inc. · Nov 1980