# DSP: System, Balloon, Intra-Aortic And Control

- Device class: 2; regulation: 21 CFR 870.3535; FDA's rule: 510(k) required
- FDA decisions: 162
- 510(k) review time 2021–2025: median 28 days (middle half 27–29)
- Recalls: 87 (47 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2011: 2
- 2012: 2
- 2013: 1
- 2015: 1
- 2017: 3
- 2018: 1
- 2019: 3
- 2020: 2
- 2023: 1
- 2025: 1

## Most-cited predicates
- K940178: Percor Stat-DL 9.5 FR.34CC & 40CC /Percor Stat-DL 10.5 FR.40CC & 50CC Intra-Aortic Balloon Modification (1994), cited by 5
- K021462: Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement System, Models Iab-05830-F,IAB5840 (2002), cited by 5
- K013326: Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope Insertion Kit for 8 FR, Polyimide Alt B (2001), cited by 5
- K964987: Datascope Percor Stat - DL 9.5 FR. 25 and 40CC Intra-Aortic Balloon for Optional Sheathless Insertion and Percor Stat -0 (1997), cited by 4
- K952221: BSC/CA 30 & 40 Sensation, Models 930 & 940 (1995), cited by 4
- K940231: Intra-Aortic Balloon for Optional Sheathless Insertion (1994), cited by 4
- K002256: Arrow Acat 2 Intra-Aortic Balloon Pump (2001), cited by 3
- K963187: Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930 - 940, 30 - 40 CC Sensation and Nicath 30C (1996), cited by 3
- K031569: Datascope CA 40 8FR. Iabs, Model 0684-00-04XX (2003), cited by 3
- K954431: Percutaneous Intra-Aortic Balloon Catheters (1996), cited by 3

Source page: https://510kreport.com/product-code/DSP
Data by year (CSV): https://510kreport.com/product-code/DSP.csv