510(k) · Cleared
Recalled · Class II · 2015Ibc Cardiac Suction Ward
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Biophysics Corp. · DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Cleared on Nov 14, 1997 after a 423-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Nov 14, 1997
- Review
- 423 days
- Class
- Class II
- Product code
- DTS
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK963756 Ibc Cardiac Suction WardInternational Biophysics Corp. · 1997
- Descendant · cites it directly · 0 of its ownK053021 Estech Clearview MV Atrial DepressorEstech, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K053021Estech Clearview MV Atrial DepressorEstech, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963756 | Ibc Cardiac Suction Ward | International Biophysics Corp. | 1997 | — |
| +1 | K053021 | Estech Clearview MV Atrial Depressor | Estech, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 DTS? 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 |
|---|---|---|---|
| * | — | Research Medical Intracardiac Sucker 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 |
|---|---|---|---|
| K053021 | Estech Clearview MV Atrial Depressor | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 7, 2015 | Class II | Z-2422-2015 | Packaging process control | It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. |
| Oct 5, 2011 | Not classified | Z-0273-2012 | Packaging | Potential for the sterility to be compromised. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K053021 (Estech, Inc., 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DTS devicesDTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTS
FDA has decided no DTS device since 2007.
Median 510(k) review, days · DTS
Too few DTS 510(k)s in any year since 2007 to give a median.
Recalls per year · DTS
2in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTS
17in 2025
MAUDE reports naming product code DTS, 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 | 1 |
| 2008 | 0 | — | 4 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 3 | 4 |
| 2012 | 0 | — | 2 | 8 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 107 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 17 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IBC Cardiac Suction Wand is intended for use by a Cardiac Surgeon during open heart surgery for the collection of blood and other fluids from the sterile surgical field for filtering and return to the patient via the Cardiotomy line. It is also intended for use by surgeons for the removal of waste fluids from the surgical field.
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/K963756 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963756: Ibc Cardiac Suction Ward.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963756
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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