510(k) · Cleared
ClearedAnivia SG1000 Pump Console
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apmtd, Inc. · DWA Control, Pump Speed, Cardiopulmonary Bypass
Cleared on Feb 3, 2023 as substantially equivalent to K131964 (Medtronic, Inc., 2013) after a 256-day review. Its family tree reaches back 6 generations to 1992. 1 of the 15 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Feb 3, 2023
- Review
- 256 days
- Class
- Class II
- Product code
- DWA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K915183 (1992). 13 ancestors in all, the oldest K871131 (1987). 1 later device descends from it, 1 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK915183 Sarns 8000 Modular Perfusion System3M Health Care, Sarns · 1992 · Recalled
- 5 generations backK953901 Sarns 800 Roller Pump3M Health Care, Sarns · 1996
- 4 generations backK022947 Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System…Terumo Cardiovascular Systems Corp. · 2003 · Recalled
- 3 generations backK070286 Bio-Console, Model 560Medtronic · 2007
- 2 generations backK080824 Bio-Console 560Medtronic Perfusion Systems · 2008
- 1 generation backK131964 Bio-Console 560 Extracorporeal Blood Pumping ConsoleMedtronic, Inc. · 2013 · Recalled (Class I)
- This deviceK221491 Anivia SG1000 Pump ConsoleApmtd, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK230698 Anivia SG1000 Pump ConsoleApmtd, Inc. · 2023
Class I recalls in this family
- K131964 Bio-Console 560 Extracorporeal Blood Pumping…direct predicate · 2013
Most influential descendants
Showing 1 of 1 · See all- K230698Anivia SG1000 Pump ConsoleApmtd, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K915183 | Sarns 8000 Modular Perfusion System | 3M Health Care, Sarns | 1992 | 45 |
| −5 | K953901 | Sarns 800 Roller Pump | 3M Health Care, Sarns | 1996 | — |
| −4 | K022947 | Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1… | Terumo Cardiovascular Systems Corp. | 2003 | 150 |
| −3 | K070286 | Bio-Console, Model 560 | Medtronic | 2007 | — |
| −2 | K080824 | Bio-Console 560 | Medtronic Perfusion Systems | 2008 | — |
| −1 | K131964 | Bio-Console 560 Extracorporeal Blood Pumping Console | Medtronic, Inc. | 2013 | Class I |
| 0 (this device) | K221491 | Anivia SG1000 Pump Console | Apmtd, Inc. | 2023 | — |
| +1 | K230698 | Anivia SG1000 Pump Console | Apmtd, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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.
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 DWA device
- #1 K232788 Inspira ART100score 7.4 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K131964 | Bio-Console 560 Extracorporeal Blood Pumping ConsoleSummary page 4…Cardiopulmonary bypass pump speed control Product Code: DWA 3. Predicate Device: A. Bio-console® 560 Extracorporeal Blood Pumping Console, K131964, Medtronic, Inc. (DWA) 4. Device Description The Anivia SG1000 Pump Console is a device for pumping blood without direct co… | 2013 |
| † | K991864 | Rotaflow Centrifugal Pump System | 2000 |
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 |
|---|---|---|---|
| K230698 | Anivia SG1000 Pump Console | 2023 | 0 |
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.
- K131964Bio-Console 560 Extracorporeal Blood Pumping ConsoleMedtronic, Inc. · 2013 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 6 companies; a new generation was cleared every 5.2 years on median.
- 6 of the 13 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K230698 (Apmtd, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DWA devicesDWA Control, Pump Speed, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · DWA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DWA
44in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWA
1in 2022
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DWA
362in 2025
MAUDE reports naming product code DWA, 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 | 1 | — | 0 | 10 |
| 2008 | 3 | 44 | 0 | 10 |
| 2009 | 2 | — | 0 | 17 |
| 2010 | 2 | — | 1 | 110 |
| 2011 | 2 | — | 0 | 147 |
| 2012 | 0 | — | 3 | 102 |
| 2013 | 2 | — | 1 | 100 |
| 2014 | 0 | — | 0 | 98 |
| 2015 | 0 | — | 0 | 103 |
| 2016 | 0 | — | 0 | 109 |
| 2017 | 0 | — | 1 | 140 |
| 2018 | 0 | — | 0 | 200 |
| 2019 | 1 | — | 0 | 376 |
| 2020 | 2 | — | 0 | 146 |
| 2021 | 0 | — | 1 | 155 |
| 2022 | 0 | — | 1 (1) | 205 |
| 2023 | 2 | — | 0 | 438 |
| 2024 | 1 | — | 0 | 389 |
| 2025 | 0 | — | 0 | 362 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Anivia SG1000 Pump Console is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass (up to 6 hours).
Contraindications:
The Anivia SG1000 Pump Console is contraindicated as a cardiotomy suction device.
It is the responsibility of the physician to determine whether any physical impairment of the patient or associated equipment would contraindicate the use of this device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221491 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221491: Anivia SG1000 Pump Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221491
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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