FDA product code DSA: Cable, Transducer And Electrode, Patient, (Including Connector)
DSA is the FDA product code for cable, transducer and electrode, patient, (including connector). It is a Class II device, regulated under 21 CFR 870.2900 and reviewed by the Cardiovascular panel. FDA has cleared 105 510(k) submissions under DSA, 13 in the last five years, from 78 different applicants. The average 510(k) review took 123 days (median 85); 100 days on average over the last three years. FDA has posted 12 recalls for DSA devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Cable, Transducer And Electrode, Patient, (Including Connector) |
| Device class | Class II |
| Regulation | 21 CFR 870.2900 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DSA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 159 |
| 2018 | 3 | 111 |
| 2019 | 4 | 122 |
| 2020 | 6 | 252 |
| 2021 | 4 | 205 |
| 2022 | 2 | 175 |
| 2023 | 3 | 257 |
| 2024 | 3 | 146 |
| 2025 | 4 | 123 |
| 2026 | 1 | 30 |
Compare with all 510(k) review times · Search every DSA clearance
Top DSA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Vascular | 5 | 1996-05-22 |
| Tronomed, Inc. | 4 | 1996-01-11 |
| Vyaire Medical, Inc. | 3 | 2021-08-16 |
| Arbo Medical, Inc. | 3 | 1995-04-12 |
| Baylis Medical Technologies, Inc. | 2 | 2026-01-18 |
73 more applicants have DSA clearances. See the full list in Caduvo.
Most recent DSA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254114 | Baylis Medical Technologies, Inc. | Baylis Connector Cable | 2026-01-18 | 30 |
| K252827 | Drägerwerk AG & Co. KGaA | IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559) | 2025-12-01 | 87 |
| K251669 | Shanghai Draeger Medical Instrument Co., Ltd. | IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter | 2025-09-30 | 123 |
| K242986 | Beijing Rongrui-Century Science & Technology Co., Ltd. | SpO2 Extension Cable | 2025-05-02 | 218 |
| K243545 | Philips Medizin Systeme Böblingen GmbH | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn | 2025-01-17 | 63 |
Recalls for DSA devices
12 product recalls in 8 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2025-01-21.
| Year | Recalls |
|---|---|
| 2019 | 7 |
| 2022 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code DSA?
DSA is the FDA product code for cable, transducer and electrode, patient, (including connector). It is a Class II device, regulated under 21 CFR 870.2900 and reviewed by the Cardiovascular panel.
What device class is DSA?
Class II, regulation 21 CFR 870.2900. Typical premarket route: 510(k).
How long does a 510(k) take for product code DSA?
Across 105 cleared submissions the average was 123 days from receipt to decision (median 85).
Which companies have the most DSA clearances?
Medtronic Vascular (5); Tronomed, Inc. (4); Vyaire Medical, Inc. (3); Arbo Medical, Inc. (3); Baylis Medical Technologies, Inc. (2).
Have DSA devices been recalled?
Yes: 12 product recalls across 8 recall events; the most recent began 2025-01-21.
Next steps
- Run an FDA pathway report with predicate devices for product code DSA
- Run a recall and safety report across every DSA manufacturer
- Watch product code DSA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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