Cleared Traditional

K842349 - AMBULATORY PH RECORDING DEVICE

K842349 is an FDA 510(k) clearance for AMBULATORY PH RECORDING DEVICE, manufactured by Clinical Data Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 364-day FDA review.

K842349 · Clinical Data Instruments, Inc. · Cardiovascular device
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Jun 1985
Decision
364d
Days
Class 2
Risk

K842349 is an FDA 510(k) clearance for the AMBULATORY PH RECORDING DEVICE. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Clinical Data Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 14, 1985 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Clinical Data Instruments, Inc. devices

FDA 510(k) Submission Details - K842349

510(k) Number K842349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1984
Decision Date June 14, 1985
Days to Decision 364 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
239d slower than avg
Panel avg: 125d · This submission: 364d
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 117
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K842349.
MODEL MR-30 HOLTER RECORDER
K860181 · Oxford Medilog, Inc. · Feb 1986
MODEL MR-35 HOLTER RECORDER
K860182 · Oxford Medilog, Inc. · Feb 1986
SERIES 7000/HOLTER RECORDER
K851971 · Pfizer, Inc. · Jun 1985
SPACELABS MODEL 90201 HOLTER RECORDER
K844940 · Spacelabs, Inc. · Feb 1985
DEL MAR AVIONICS 509 NEUROCORDER AMBUL
K841654 · Del Mar Avionics · Dec 1984
MINGOGRAF 7
K841868 · Siemens Medical Solutions USA, Inc. · Oct 1984