Cleared Traditional

K782131 - PULSETAKER

K782131 is an FDA 510(k) clearance for PULSETAKER, manufactured by Van, Cott, Bagley, Cornwall & Mccarth. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K782131 · Van, Cott, Bagley, Cornwall & Mccarth · Cardiovascular device
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Jan 1979
Decision
19d
Days
Class 2
Risk

K782131 is an FDA 510(k) clearance for the PULSETAKER. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Van, Cott, Bagley, Cornwall & Mccarth (Mchenry, US). The FDA issued a Cleared decision on January 15, 1979 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Van, Cott, Bagley, Cornwall & Mccarth devices

FDA 510(k) Submission Details - K782131

510(k) Number K782131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1978
Decision Date January 15, 1979
Days to Decision 19 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 125d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 229
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K782131.
AS7 & AS8 MONITORS
K790552 · Narco Air-Shields · May 1979
MODEL 78801A PATIENT MONITORS
K790454 · Hewlett-Packard Co. · Apr 1979
MONITOR, ELECTROCARDIOSCOPE
K790292 · Burdick Corp. · Feb 1979
CARDIAC MINISCOPE & MINIGRAPH
K780297 · Arco Medical Products Co. · May 1978
CSS-60 DIGITAL HEART RATE METER
K780702 · Burdick Corp. · May 1978
ECG MONITORING SYSTEM,
K780404 · Quinton, Inc. · Mar 1978