510(k) · Cleared
ClearedAutomatic Tubing Clamp System (Atc)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rocky Mountain Research, Inc. · KRL Detector, Bubble, Cardiopulmonary Bypass
Cleared on Oct 31, 1996 after a 205-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 10 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Oct 31, 1996
- Review
- 205 days
- Class
- Class II
- Product code
- KRL
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- This deviceK961364 Automatic Tubing Clamp System (Atc)Rocky Mountain Research, Inc. · 1996
- Descendant · cites it directly · 6 of its ownK070286 Bio-Console, Model 560Medtronic · 2007
- Descendant · 2 generations on · 3 of its ownK080824 Bio-Console 560Medtronic Perfusion Systems · 2008
- Descendant · 3 generations on · 2 of its ownK131964 Bio-Console 560 Extracorporeal Blood Pumping ConsoleMedtronic, Inc. · 2013 · Recalled (Class I)
- Descendant · 4 generations on · 1 of its ownK221491 Anivia SG1000 Pump ConsoleApmtd, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK070213 Performer CBP SystemRand S.R.L. · 2007 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K131964 Bio-Console 560 Extracorporeal Blood Pumping…3 generations on · 2013
Most influential descendants
Showing 5 of 9 · See all- K070286Bio-Console, Model 560Medtronic · 2007 · cites it directly6descendants
- K080824Bio-Console 560Medtronic Perfusion Systems · 2008 · 2 generations on3descendants
- K131964Bio-Console 560 Extracorporeal Blood Pumping ConsoleMedtronic, Inc. · 2013 · 3 generations on2descendants
- K221491Anivia SG1000 Pump ConsoleApmtd, Inc. · 2023 · 4 generations on1descendant
- K070213Performer CBP SystemRand S.R.L. · 2007 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961364 | Automatic Tubing Clamp System (Atc) | Rocky Mountain Research, Inc. | 1996 | — |
| +1 | K070286 | Bio-Console, Model 560 | Medtronic | 2007 | — |
| +2 | K080824 | Bio-Console 560 | Medtronic Perfusion Systems | 2008 | — |
| +3 | K131964 | Bio-Console 560 Extracorporeal Blood Pumping Console | Medtronic, Inc. | 2013 | Class I |
| +4 | K221491 | Anivia SG1000 Pump Console | Apmtd, Inc. | 2023 | — |
| +1 | K070213 | Performer CBP System | Rand S.R.L. | 2007 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 1 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2023 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K070286 (Medtronic, 2007) has gone furthest, with 6 descendants of its own.
How does its category compare?
All KRL devicesKRL Detector, Bubble, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KRL
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · KRL
Too few KRL 510(k)s in any year since 2007 to give a median.
Recalls per year · KRL
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRL
4in 2024
MAUDE reports naming product code KRL, 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 | — | 3 | 10 |
| 2008 | 0 | — | 0 | 26 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 1 | 3 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 20 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K961364 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961364: Automatic Tubing Clamp System (Atc).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961364
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026