510(k) · Cleared
ClearedOrqis Extracorporeal Blood Pumping System, Model BPS-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orqis Medical Corporation · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Jun 27, 2008 as substantially equivalent to K020271 (Levitronix, LLC, 2003) and 2 other predicates after a 184-day review. Its family tree reaches back 4 generations to 1985. 1 of the 11 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 27, 2008
- Review
- 184 days
- Class
- Class II
- Product code
- KFM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K852698 (1985). 10 ancestors in all, the oldest K780953 (1978). No later device cites it as a predicate yet. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
- 3 generations backK973011 BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998
- 2 generations backK991783 AB-180 XC System, Model AB-180XCCardiacassist, Inc. · 2000
- 1 generation backK061369 Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500Cardiacassist, Inc. · 2006
- This deviceK073631 Orqis Extracorporeal Blood Pumping System, Model BPS-100Orqis Medical Corporation · 2008
Class I recalls in this family
- K020271 Levitronix Centrimag Extracorporeal Blood…direct predicate · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K852698 | Bio Medicus Bio Pump Model BP-80 | Bio Medicus, Inc. | 1985 | — |
| −3 | K973011 | BPX80 Bio-Pump (BPX80) | Medtronic Bio-Medicus, Inc. | 1998 | — |
| −2 | K991783 | AB-180 XC System, Model AB-180XC | Cardiacassist, Inc. | 2000 | — |
| −1 | K061369 | Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500 | Cardiacassist, Inc. | 2006 | — |
| 0 (this device) | K073631 | Orqis Extracorporeal Blood Pumping System, Model BPS-100 | Orqis Medical Corporation | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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? (3)
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 |
|---|---|---|---|
| * | K020271 | Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Summary page 1…870.4390) Predicate Devices: Levitronix CentriMag® Extracorporeal Blood Pumping System, K020271 Cardiac Assist TandemHeart Escort Controller, K061369… | 2003 |
| * | K061369 | Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500Summary page 1…mping System, K020271 Cardiac Assist TandemHeart Escort Controller, K061369 Olsen Medical Sales Plastron Pump Tubing, K01 3578 Device Description: The Orqis… | 2006 |
| * | K013578 | Pump TubingSummary page 1…Cardiac Assist TandemHeart Escort Controller, K061369 Olsen Medical Sales Plastron Pump Tubing, K01 3578 Device Description: The Orqis Extracorporeal Blood Pumping System consists of a p… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K020271Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 2003 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 4 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
- 9 other devices also cite its predicate K020271.
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. 2008, this device’s year, is highlighted.
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 Orqis Extracorporeal Blood Pumping system is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants, etc).
The Orqis Pump Tubing is indicated for use in extracorporeal circuits for circulatory support lasting six-hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073631 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073631: Orqis Extracorporeal Blood Pumping System, Model BPS-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073631
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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