510(k) · Cleared
ClearedIbc VRV, Model 1350
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Biophysics Corp. · DWD Suction Control, Intracardiac, Cardiopulmonary Bypass
Cleared on Feb 18, 2000 after a 193-day review. The FDA summary names its predicate without a number.
- Decided
- Feb 18, 2000
- Review
- 193 days
- Class
- Class II
- Product code
- DWD
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 DWD? 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 |
|---|---|---|---|
| * | — | Omni Model RLV-2100"B” VRV valve Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All DWD devicesDWD Suction Control, Intracardiac, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWD
FDA has decided no DWD device since 2007.
Median 510(k) review, days · DWD
Too few DWD 510(k)s in any year since 2007 to give a median.
Recalls per year · DWD
No recall names DWD since 2007.
Adverse event reports per year · DWD
1in 2024
MAUDE reports naming product code DWD, 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 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 38 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IBC VRV is indicated for use as an intracardiac suction control valve for left ventricular venting during cardiopulmonary bypass surgery (up to six hours).
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/K992657 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992657: Ibc VRV, Model 1350.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992657
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026