510(k) · Cleared
ClearedIbc Flopump with GBS Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gish Biomedical, Inc. · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on May 14, 2003 as substantially equivalent to K983272 (International Biophysics Corp., 1999) and 1 other predicate after a 20-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- May 14, 2003
- Review
- 20 days
- Class
- Class II
- Product code
- KFM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K922933 (1992). 6 ancestors in all, the oldest K852698 (1985). No later device cites it as a predicate yet.
- Root · 3 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 2 generations backK961530 Gish Reliance Oxygenator (Model Hfo)Gish Biomedical, Inc. · 1996 · Recalled
- 1 generation backK023381 Vision Hollow Fiber Oxygenator with Guardian CoatingGish Biomedical, Inc. · 2003 · Recalled
- This deviceK031300 Ibc Flopump with GBS CoatingGish Biomedical, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −2 | K961530 | Gish Reliance Oxygenator (Model Hfo) | Gish Biomedical, Inc. | 1996 | 1 |
| −1 | K023381 | Vision Hollow Fiber Oxygenator with Guardian Coating | Gish Biomedical, Inc. | 2003 | 2 |
| 0 (this device) | K031300 | Ibc Flopump with GBS Coating | Gish Biomedical, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1999 | 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 KFM? 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 KFM device
- #1 K250326 Quantum Perfusion Centrifugal Blood Pump…score 11.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K983272 | Ibc Flopump, Model 6000Summary page 1…Classification Name: Nonroller-type cardiopulmonary bypass blood pump 3. Predicate Devices: IBC FloPump, International Biophysics Corporation, K983272. Pump. Vision Hollow Fiber Oxygenator with GBSTMcoating, K023381. Coating. 4. Classifications Names & Citations:… | 1999 |
| * | K023381 | Vision Hollow Fiber Oxygenator with Guardian CoatingSummary page 1…mp 3. Predicate Devices: IBC FloPump, International Biophysics Corporation, K983272. Pump. Vision Hollow Fiber Oxygenator with GBSTMcoating, K023381. Coating. 4. Classifications Names & Citations: 5. 21 CFR 870.4360, Nonroller-type cardiopulmonary bypass blood pump,… | 2003 |
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.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K983272.
How does its category compare?
All KFM devicesKFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KFM
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KFM
30in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KFM
2in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KFM
249in 2025
MAUDE reports naming product code KFM, 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 | 60 |
| 2008 | 4 | 194 | 2 | 62 |
| 2009 | 5 | 184 | 4 | 85 |
| 2010 | 3 | 109 | 2 | 81 |
| 2011 | 7 | 16 | 1 | 57 |
| 2012 | 0 | — | 5 | 82 |
| 2013 | 2 | — | 0 | 104 |
| 2014 | 0 | — | 0 | 347 |
| 2015 | 0 | — | 0 | 299 |
| 2016 | 0 | — | 0 | 156 |
| 2017 | 1 | — | 0 | 121 |
| 2018 | 0 | — | 1 | 176 |
| 2019 | 3 | 147 | 3 (1) | 311 |
| 2020 | 3 | 30 | 0 | 437 |
| 2021 | 3 | 534 | 0 | 446 |
| 2022 | 0 | — | 0 | 294 |
| 2023 | 3 | 30 | 0 | 346 |
| 2024 | 0 | — | 2 | 296 |
| 2025 | 2 | — | 0 | 249 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IBC FloPump with GBSTMCoating centrifugal blood pump is indicated for use only with the Medtronic Bio-Medicus Bio Console0 to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support at flow rates of up to seven (7.0) LPM for periods up to six (6.0) hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031300: Ibc Flopump with GBS Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031300
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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