Cleared Traditional

K922221 - SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM

K922221 · Del Mar Avionics · Cardiovascular device
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Apr 1993
Decision
344d
Days
-
Risk

K922221 is an FDA 510(k) clearance for the SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM.

Submitted by Del Mar Avionics (Irvine, US). The FDA issued a Cleared decision on April 21, 1993 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel. 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 Del Mar Avionics devices

FDA 510(k) Submission Details - K922221

510(k) Number K922221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1992
Decision Date April 21, 1993
Days to Decision 344 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
219d slower than avg
Panel avg: 125d · This submission: 344d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 59
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K922221.
CARDIOFAX Q ECG-8420A
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MARQUETTE SL SERIES TRANSPORT REMOTE ACQUISITION
K921669 · Marquette Electronics, Inc. · May 1993
MORTARA INSTRUMENT ODEL ELI 50I
K915730 · Mortara Instrument, Inc. · Nov 1992
MODEL ELI 200 ELECTROCARDIOGRAPH
K920626 · Mortara Instrument, Inc. · Sep 1992
MODEL ELI 100 ELECTROCARDIOGRAPH
K920627 · Mortara Instrument, Inc. · Sep 1992