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FDA product code · Cardiovascular · Class 2

DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

DSA is FDA's product code for "Cable, Transducer And Electrode, Patient, (Including Connector)": a Class 2 device classified under 21 CFR 870.2900, reviewed by the Cardiovascular panel.

510(k) review time for DSA

Across 30 510(k) clearances under DSA decided from 2018-01-01 to 2026-10-06, the median was 130 days from FDA receipt to decision. Half took between 90 and 218 days, and 80% were decided within 225 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, DSA, decisions 2018-01-01 to 2026-10-06 (n = 30)
Fastest26
25th percentile90
Median130
75th percentile218
80th percentile225
90th percentile308
Slowest632

Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.

DSA in the public FDA record

Records naming DSA, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years105
Device recalls12
Establishment listings315
GUDID device identifiers12,366

Counts of records, not of devices or events. Adverse event reports for DSA are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.

FDA-recognized standards that cite DSA

3 FDA recognized consensus standards cite DSA, 1 of them recognized only in part, among them IEC 60601-2-31 Edition 2.1 2011-09; ANSI AAMI EC53:2013/(R)2020; IEC 60601-2-31 Edition 3.0 2020-01. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 3-102 IEC 60601-2-31 Edition 2.1 2011-09 — Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
  • 3-129 ANSI AAMI EC53:2013/(R)2020 (partial recognition) — ECG trunk cables and patient leadwires
  • 3-201 IEC 60601-2-31 Edition 3.0 2020-01 — Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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