Cleared Traditional

K834257 - CARDIODATA PACE RECORDER

K834257 is an FDA 510(k) clearance for CARDIODATA PACE RECORDER, manufactured by Cardio Data. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K834257 · Cardio Data · Cardiovascular device
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Jan 1984
Decision
54d
Days
Class 2
Risk

K834257 is an FDA 510(k) clearance for the CARDIODATA PACE RECORDER. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Cardio Data (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 Cardio Data devices

FDA 510(k) Submission Details - K834257

510(k) Number K834257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1983
Decision Date January 30, 1984
Days to Decision 54 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 125d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSH Device Classification - Class 2, Special Controls

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - DSH Recorder, Magnetic Tape, Medical

All 122
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K834257.
MINGOGRAF 7
K841868 · Siemens Medical Solutions USA, Inc. · Oct 1984
RESPIRATION/8100-HEART RATE RECORDER
K833348 · Aequitron Medical, Inc. · Apr 1984
EVENT TAPE RECORDER 8293
K833349 · Aequitron Medical, Inc. · Apr 1984
ELECTROCARDIOCORDER RECORDER 453
K833661 · Del Mar Avionics · Nov 1983
AMBULATORY ECG EVENT RECORDER
K830907 · Brentwood Instruments, Inc. · Jul 1983
OMAR
K830915 · Oxford Medilog, Inc. · Jul 1983