Cleared Traditional

K860182 - MODEL MR-35 HOLTER RECORDER

K860182 is an FDA 510(k) clearance for MODEL MR-35 HOLTER RECORDER, manufactured by Oxford Medilog, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K860182 · Oxford Medilog, Inc. · Cardiovascular device
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Feb 1986
Decision
36d
Days
Class 2
Risk

K860182 is an FDA 510(k) clearance for the MODEL MR-35 HOLTER RECORDER. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Oxford Medilog, Inc. (Clearwater, US). The FDA issued a Cleared decision on February 26, 1986 after a review of 36 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 Oxford Medilog, Inc. devices

FDA 510(k) Submission Details - K860182

510(k) Number K860182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1986
Decision Date February 26, 1986
Days to Decision 36 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 125d · This submission: 36d
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 74
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K860182.
NIGHTWATCH(TM) SYSTEM
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K860181 · Oxford Medilog, Inc. · Feb 1986
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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