Cleared Traditional

K842349 - AMBULATORY PH RECORDING DEVICE

K842349 is the FDA 510(k) clearance for AMBULATORY PH RECORDING DEVICE by Clinical Data Instruments, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 74
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K842349.
MODEL 509A PHYSIOCORDER AMBULATORY RECORDER
K854269 · Del Mar Avionics · Apr 1986
MODEL MR-30 HOLTER RECORDER
K860181 · Oxford Medilog, Inc. · Feb 1986
MODEL MR-35 HOLTER RECORDER
K860182 · Oxford Medilog, Inc. · Feb 1986
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