510(k) · Cleared
ClearedHeart-Lift Balloon Positioner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiothoracic Systems, Inc. · MWS Stabilizer, Heart
Cleared on Jan 13, 1999 after a 184-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jan 13, 1999
- Review
- 184 days
- Class
- Class I
- Product code
- MWS
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK982419 Heart-Lift Balloon PositionerCardiothoracic Systems, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK070034 Reprocessed Guidant Cardiac Stabilization and Positioning DevicesAscent Healthcare Solutions · 2007
Most influential descendants
Showing 1 of 1 · See all- K070034Reprocessed Guidant Cardiac Stabilization and Positioning DevicesAscent Healthcare Solutions · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982419 | Heart-Lift Balloon Positioner | Cardiothoracic Systems, Inc. | 1999 | — |
| +1 | K070034 | Reprocessed Guidant Cardiac Stabilization and Positioning Devices | Ascent Healthcare Solutions | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 MWS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | Baxter Janke-Barron Heart Support Named without a submission number |
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 |
|---|---|---|---|
| K070034 | Reprocessed Guidant Cardiac Stabilization and Positioning Devices | 2007 | 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?
- Of its descendants, K070034 (Ascent Healthcare Solutions, 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MWS devicesMWS Stabilizer, Heart: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWS
FDA has decided no MWS device since 2007.
Median 510(k) review, days · MWS
Too few MWS 510(k)s in any year since 2007 to give a median.
Recalls per year · MWS
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWS
63in 2025
MAUDE reports naming product code MWS, 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 | 0 | — | 0 | 27 |
| 2008 | 0 | — | 0 | 8 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 16 |
| 2011 | 0 | — | 2 | 90 |
| 2012 | 0 | — | 0 | 20 |
| 2013 | 0 | — | 0 | 22 |
| 2014 | 0 | — | 1 | 34 |
| 2015 | 0 | — | 0 | 66 |
| 2016 | 0 | — | 0 | 52 |
| 2017 | 0 | — | 0 | 45 |
| 2018 | 0 | — | 0 | 54 |
| 2019 | 0 | — | 0 | 59 |
| 2020 | 0 | — | 0 | 43 |
| 2021 | 0 | — | 0 | 74 |
| 2022 | 0 | — | 0 | 98 |
| 2023 | 0 | — | 2 | 67 |
| 2024 | 0 | — | 3 | 56 |
| 2025 | 0 | — | 0 | 63 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
The CTS Heart-LIFT Balloon Positioner is a surgical instrument intended to lift and position the heart during cardiac surgery.
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/K982419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982419: Heart-Lift Balloon Positioner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982419
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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