Cleared Traditional

K922221 - SPRINT DX

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

Submission Details

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.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 43
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K922221.
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SPACE LABS MODEL 90560
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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