510(k) · Cleared
ClearedSidewinder 40CC DL Intra-Aortic Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · DSP System, Balloon, Intra-Aortic And Control
Cleared on Mar 6, 1990 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 150 later devices descend from it.
- Decided
- Mar 6, 1990
- Review
- 84 days
- Class
- Class II
- Product code
- DSP
- Recalls
- None
- Predicates
- 0
150 later devices descend from it, 1 citing it directly.
- This deviceK896920 Sidewinder 40CC DL Intra-Aortic Balloon CatheterBoston Scientific Corp · 1990
- Descendant · cites it directly · 149 of its ownK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 119 of its ownK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
- Descendant · 3 generations on · 88 of its ownK032733 PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004
- Descendant · 4 generations on · 87 of its ownK043348 Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- Descendant · 2 generations on · 75 of its ownK020550 Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp. · 2002 · Recalled
Showing 5 of 150 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 150 · See all- K972502Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · cites it directly149descendants
- K993531Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · 2 generations on119descendants
- K032733PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004 · 3 generations on88descendants
- K043348Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005 · 4 generations on87descendants
- K020550Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp. · 2002 · 2 generations on75descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K896920 | Sidewinder 40CC DL Intra-Aortic Balloon Catheter | Boston Scientific Corp | 1990 | — |
| +1 | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | Spacelabs Medical, Inc. | 1998 | 3 |
| +2 | K993531 | Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX | Datascope Corp. | 2000 | 1 |
| +3 | K032733 | PM-8000 Patient Monitor, Model 8000 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2004 | — |
| +4 | K043348 | Modification to PM-8000 Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| +2 | K020550 | Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX | Datascope Corp. | 2002 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 10 | 0 |
| 2010 | 10 | 0 |
| 2011 | 5 | 0 |
| 2012 | 6 | 0 |
| 2013 | 7 | 0 |
| 2014 | 9 | 0 |
| 2015 | 10 | 0 |
| 2016 | 7 | 0 |
| 2017 | 9 | 0 |
| 2018 | 8 | 0 |
| 2019 | 7 | 0 |
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 7 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DSP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DSP device
- #1 K250542 AC3™ Range™ Intra-Aortic Balloon Pumpscore 11.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (150)
See all 1501 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | 1998 | 149 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K972502 (Spacelabs Medical, Inc., 1998) has gone furthest, with 149 descendants of its own.
How does its category compare?
All DSP devicesDSP System, Balloon, Intra-Aortic And Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSP
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSP
140in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSP
4in 2025
Class I (47 since 2007) Class II/III not classified
Adverse event reports per year · DSP
7,422in 2025
MAUDE reports naming product code DSP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 3 | 461 |
| 2008 | 0 | — | 0 | 617 |
| 2009 | 2 | — | 14 | 656 |
| 2010 | 0 | — | 8 | 1,019 |
| 2011 | 2 | — | 0 | 590 |
| 2012 | 2 | — | 3 | 490 |
| 2013 | 1 | — | 0 | 495 |
| 2014 | 0 | — | 1 | 1,738 |
| 2015 | 1 | — | 0 | 404 |
| 2016 | 0 | — | 9 (9) | 419 |
| 2017 | 3 | 73 | 0 | 2,164 |
| 2018 | 1 | — | 2 (2) | 3,331 |
| 2019 | 3 | 140 | 3 | 3,552 |
| 2020 | 2 | — | 0 | 3,393 |
| 2021 | 0 | — | 5 (3) | 4,345 |
| 2022 | 0 | — | 33 (33) | 5,113 |
| 2023 | 1 | — | 0 | 6,980 |
| 2024 | 0 | — | 1 | 7,317 |
| 2025 | 1 | — | 4 | 7,422 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K896920 · printed Nov 4, 2026
Cite this page
510(k) Report. “K896920: Sidewinder 40CC DL Intra-Aortic Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K896920
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026