510(k) · Cleared
Cleared40 CC Sumo
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 Aug 5, 1997 as substantially equivalent to K963187 (Boston Scientific Corp, 1996) and 4 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- Aug 5, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- DSP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K892222 (1990). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK892222 9.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1990
- 1 generation backK963187 Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters…Boston Scientific Corp · 1996
- This deviceK971673 40 CC SumoBoston Scientific Corp · 1997
- Descendant · cites it directly · 0 of its ownK974247 40 CC GrandeBoston Scientific Corp · 1998
Most influential descendants
Showing 1 of 1 · See all- K97424740 CC GrandeBoston Scientific Corp · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K892222 | 9.5F Percu Double Lumen Intra-Aortic Balloon | Kontron Instruments, Inc. | 1990 | — |
| −1 | K963187 | Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930… | Boston Scientific Corp | 1996 | — |
| 0 (this device) | K971673 | 40 CC Sumo | Boston Scientific Corp | 1997 | — |
| +1 | K974247 | 40 CC Grande | Boston Scientific Corp | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K963187 | Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930 - 940, 30…Summary page 1…. PREDICATE DEVICE INFORMATION The following devices are referenced in this premarket notification as predicate devices for the 40 cc SUMO, subject of this submission: K963187: Modified Labeling of BSC/CA |AB’s. K954431: Modified Model 940 and Model 930 for use on BSC/CA 3001, Datascope Systems 90 and… | 1996 |
| * | K954431 | Percutaneous Intra-Aortic Balloon CathetersSummary page 1…devices are referenced in this premarket notification as predicate devices for the 40 cc SUMO, subject of this submission: K963187: Modified Labeling of BSC/CA |AB’s. K954431: Modified Model 940 and Model 930 for use on BSC/CA 3001, Datascope Systems 90 and 97, St. Jude/Aries 700, Kontron KAAT and Bard… | 1996 |
| * | K952221 | BSC/CA 30 & 40 Sensation, Models 930 & 940Summary page 1…ling of BSC/CA |AB’s. K954431: Modified Model 940 and Model 930 for use on BSC/CA 3001, Datascope Systems 90 and 97, St. Jude/Aries 700, Kontron KAAT and Bard H-8000. K952221: 30 and 40 cc Sensation™, Model 940 and Model 930 for use on Bard H-8000. K943919: 40 cc Sensation™ for use on Datascope System… | 1995 |
| * | K943919 | 9.5 FR Sensation DL Intra-Aortic Ballon CatheterSummary page 1…3001, Datascope Systems 90 and 97, St. Jude/Aries 700, Kontron KAAT and Bard H-8000. K952221: 30 and 40 cc Sensation™, Model 940 and Model 930 for use on Bard H-8000. K943919: 40 cc Sensation™ for use on Datascope System 97 and St. Jude/Aries 700. K940298: Model 940 for use on BSC/CA 3001, Datascope Sy… | 1995 |
| * | K940298 | BSC/CA Model 940 IabSummary page 1…00. K952221: 30 and 40 cc Sensation™, Model 940 and Model 930 for use on Bard H-8000. K943919: 40 cc Sensation™ for use on Datascope System 97 and St. Jude/Aries 700. K940298: Model 940 for use on BSC/CA 3001, Datascope Systems 90 and 97, Kontron KAAT and St. Jude/Aries 700. 000373 FDA… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974247 | 40 CC Grande | 1998 | 0 |
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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K974247 (Boston Scientific Corp, 1998) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K963187.
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 | — |
What is it indicated for?
The BSC/CA IABCs are indicated for use in patients with the following conditions: Refractory power failure. Cardiogenic shock. Unstable refractory angina. Hemodynamically significant mechanical complications secondary to acute MI: Ventricular septal defect. Mitral valve regurgitation. Papillary muscle rupture. Cardiac support for high risk general surgical and coronary angiography/angioplasty patients. Septic shock. The intended use of the 40 cc SUMO…
Read the full statement (214 words)
The BSC/CA IABCs are indicated for use in patients with the following conditions:
Refractory power failure.
Cardiogenic shock.
Unstable refractory angina.
Hemodynamically significant mechanical complications secondary to acute MI:
Ventricular septal defect.
Mitral valve regurgitation.
Papillary muscle rupture.
Cardiac support for high risk general surgical and coronary angiography/angioplasty patients.
Septic shock.
The intended use of the 40 cc SUMO remains identical to that of the currently marketed IABCs. All of the devices are intended to provide temporary circulatory support of the left ventricle through controlled mechanical displacement of a volume of blood in the aorta.
The mechanical action of the IAB catheter therapy lowers the cardiac workload by two means:
1. Systolic unloading, as noted by a reduction in the patient's systolic pressure, which provides reduced myocardial oxygen consumption (MVO2).
2. Diastolic augmentation which provides an increase in the mean aortic pressure and leads to an improvement in systemic and coronary arterial perfusion.
Balloon pump therapy is achieved by inserting an intra-aortic balloon catheter into the descending thoracic aorta via the common femoral artery. Balloon inflation is timed to occur during diastole, beginning with the aortic valve closure. The balloon remains inflated until the onset of left ventricular ejection or systole, then rapidly deflates, reducing the aortic pressure, which in turn reduces the afterload.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971673 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971673: 40 CC Sumo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971673
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026