FDA product code DSP: System, Balloon, Intra-Aortic And Control
DSP is the FDA product code for system, balloon, intra-aortic and control. It is a Class II device, regulated under 21 CFR 870.3535 and reviewed by the Cardiovascular panel. FDA has cleared 162 510(k) submissions under DSP, 2 in the last five years, from 22 different applicants. The average 510(k) review took 171 days (median 123); 30 days on average over the last three years. FDA has posted 194 recalls for DSP devices, 90 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Balloon, Intra-Aortic And Control |
| Device class | Class II |
| Regulation | 21 CFR 870.3535 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for DSP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 98 |
| 2018 | 1 | 31 |
| 2019 | 3 | 127 |
| 2020 | 2 | 30 |
| 2023 | 1 | 26 |
| 2025 | 1 | 30 |
Compare with all 510(k) review times · Search every DSP clearance
Top DSP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Datascope Corp. | 64 | 2018-05-31 |
| Kontron Instruments, Inc. | 17 | 1993-12-15 |
| Arrow Intl., Inc. | 15 | 2006-04-06 |
| Boston Scientific Corp | 14 | 1998-02-10 |
| Aries Medical, Inc. | 8 | 1990-04-10 |
17 more applicants have DSP clearances. See the full list in Caduvo.
Most recent DSP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250542 | Arrow International, LLC | AC3 Range Intra-Aortic Balloon Pump | 2025-03-26 | 30 |
| K232343 | Arrow International, LLC | AC3 Series IABP | 2023-08-30 | 26 |
| K201112 | Arrow International, Inc. | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP | 2020-05-27 | 30 |
| K200634 | Arrow International, Inc. | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit | 2020-04-09 | 30 |
| K192238 | Arrow International, Teleflex | AC3 Series Intra-Aortic Balloon Pump (IABP) | 2019-11-12 | 85 |
Recalls for DSP devices
194 product recalls in 62 recall events; 90 initiated in the last five years and 125 still open. Most recent: 2026-02-06.
| Year | Recalls |
|---|---|
| 2017 | 7 |
| 2018 | 6 |
| 2019 | 10 |
| 2020 | 27 |
| 2021 | 9 |
| 2022 | 36 |
| 2023 | 36 |
| 2024 | 8 |
| 2025 | 5 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code DSP?
DSP is the FDA product code for system, balloon, intra-aortic and control. It is a Class II device, regulated under 21 CFR 870.3535 and reviewed by the Cardiovascular panel.
What device class is DSP?
Class II, regulation 21 CFR 870.3535. Typical premarket route: 510(k).
How long does a 510(k) take for product code DSP?
Across 162 cleared submissions the average was 171 days from receipt to decision (median 123).
Which companies have the most DSP clearances?
Datascope Corp. (64); Kontron Instruments, Inc. (17); Arrow Intl., Inc. (15); Boston Scientific Corp (14); Aries Medical, Inc. (8).
Have DSP devices been recalled?
Yes: 194 product recalls across 62 recall events; the most recent began 2026-02-06.
Next steps
- Run an FDA pathway report with predicate devices for product code DSP
- Run a recall and safety report across every DSP manufacturer
- Watch product code DSP 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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