Cleared Traditional

K844940 - SPACELABS MODEL 90201 HOLTER RECORDER

K844940 is an FDA 510(k) clearance for SPACELABS MODEL 90201 HOLTER RECORDER, manufactured by Spacelabs, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K844940 · Spacelabs, Inc. · Cardiovascular device
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Feb 1985
Decision
56d
Days
Class 2
Risk

K844940 is an FDA 510(k) clearance for the SPACELABS MODEL 90201 HOLTER RECORDER. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Spacelabs, Inc. (Chatsworth, US). The FDA issued a Cleared decision on February 14, 1985 after a review of 56 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 Spacelabs, Inc. devices

FDA 510(k) Submission Details - K844940

510(k) Number K844940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1984
Decision Date February 14, 1985
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
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 78
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K844940.
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
DEL MAR AVIONICS 509 NEUROCORDER AMBUL
K841654 · Del Mar Avionics · Dec 1984
MINGOGRAF 7
K841868 · Siemens Medical Solutions USA, Inc. · Oct 1984
RESPIRATION/8100-HEART RATE RECORDER
K833348 · Aequitron Medical, Inc. · Apr 1984