510(k) · Cleared
ClearedRmi Aortic Root/Coronary Sinus Pressure Monitoring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Research Medical, Inc. · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Cleared on Mar 27, 1990 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Mar 27, 1990
- Review
- 90 days
- Class
- Class II
- Product code
- DTL
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK897137 Rmi Aortic Root/Coronary Sinus Pressure MonitoringResearch Medical, Inc. · 1990
- Descendant · cites it directly · 3 of its ownK961270 Heartport Endosinus CatheterHeartport, Inc. · 1996
- Descendant · 2 generations on · 1 of its ownK964248 Heartport Endocoronary Sinus CathetrHeartport, Inc. · 1997 · Recalled
- Descendant · 3 generations on · 0 of its ownK090869 Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion)…Medtronic Perfusion Systems · 2009
- Descendant · 2 generations on · 0 of its ownK962858 Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem…Heartport, Inc. · 1996
Most influential descendants
Showing 4 of 4 · See all- K961270Heartport Endosinus CatheterHeartport, Inc. · 1996 · cites it directly3descendants
- K964248Heartport Endocoronary Sinus CathetrHeartport, Inc. · 1997 · 2 generations on1descendant
- K090869Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula…Medtronic Perfusion Systems · 2009 · 3 generations on0descendants
- K962858Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog Number…Heartport, Inc. · 1996 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K897137 | Rmi Aortic Root/Coronary Sinus Pressure Monitoring | Research Medical, Inc. | 1990 | — |
| +1 | K961270 | Heartport Endosinus Catheter | Heartport, Inc. | 1996 | — |
| +2 | K964248 | Heartport Endocoronary Sinus Cathetr | Heartport, Inc. | 1997 | 2 |
| +3 | K090869 | Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate… | Medtronic Perfusion Systems | 2009 | — |
| +2 | K962858 | Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog… | Heartport, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2009 | 1 | 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.
Planning a device in DTL? 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K961270 | Heartport Endosinus Catheter | 1996 | 3 |
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?
- Of its descendants, K961270 (Heartport, Inc., 1996) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DTL devicesDTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTL
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · DTL
36in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTL
1in 2025
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DTL
110in 2025
MAUDE reports naming product code DTL, 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 | 37 |
| 2008 | 5 | 85 | 1 | 16 |
| 2009 | 2 | — | 0 | 62 |
| 2010 | 4 | 115 | 3 | 148 |
| 2011 | 0 | — | 1 | 160 |
| 2012 | 8 | 36 | 2 | 53 |
| 2013 | 1 | — | 1 (1) | 67 |
| 2014 | 2 | — | 1 | 80 |
| 2015 | 1 | — | 0 | 89 |
| 2016 | 0 | — | 0 | 67 |
| 2017 | 0 | — | 2 | 106 |
| 2018 | 0 | — | 0 | 84 |
| 2019 | 0 | — | 0 | 76 |
| 2020 | 0 | — | 0 | 53 |
| 2021 | 0 | — | 0 | 55 |
| 2022 | 0 | — | 2 | 48 |
| 2023 | 0 | — | 0 | 46 |
| 2024 | 0 | — | 0 | 452 |
| 2025 | 0 | — | 1 | 110 |
| 2026 | 0 | — | 3 (3) | — |
https://510kreport.com/device/K897137 · printed Nov 4, 2026
Cite this page
510(k) Report. “K897137: Rmi Aortic Root/Coronary Sinus Pressure Monitoring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K897137
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026