Cleared Traditional

K851971 - SERIES 7000/HOLTER RECORDER

K851971 is an FDA 510(k) clearance for SERIES 7000/HOLTER RECORDER, manufactured by Pfizer, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K851971 · Pfizer, Inc. · Cardiovascular device
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Jun 1985
Decision
44d
Days
Class 2
Risk

K851971 is an FDA 510(k) clearance for the SERIES 7000/HOLTER RECORDER. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Pfizer, Inc. (Milwaukee, US). The FDA issued a Cleared decision on June 20, 1985 after a review of 44 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.

FDA 510(k) Submission Details - K851971

510(k) Number K851971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1985
Decision Date June 20, 1985
Days to Decision 44 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
81d faster than avg
Panel avg: 125d · This submission: 44d
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 192
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K851971.
MODEL MR-35 HOLTER RECORDER
K860182 · Oxford Medilog, Inc. · Feb 1986
MVM 4000 HOLTER IV RECORDER
K853985 · Mountain View Medical · Nov 1985
CARDIO DATA PACERECORDER PR3
K853262 · Cardio Data · Oct 1985
AMBULATORY PH RECORDING DEVICE
K842349 · Clinical Data Instruments, Inc. · Jun 1985
SPACELABS MODEL 90201 HOLTER RECORDER
K844940 · Spacelabs, Inc. · Feb 1985
HOLTER CURA-LITE RECORDER
K844977 · Cardionostics, Inc. · Jan 1985
K851971 · SERIES 7000/HOLTER RECORDER
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