510(k) · Cleared
ClearedTerumo Rocsafe Hybrid Perfusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corp. · KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cleared on Feb 13, 2009 as substantially equivalent to K062381 (Terumo Cardiovascular Systems Corp., 2006) and 6 other predicates after a 184-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Feb 13, 2009
- Review
- 184 days
- Class
- Class II
- Product code
- KFM
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 6 generations to K915573 (1992). 24 ancestors in all, the oldest K842908 (1985). No later device cites it as a predicate yet.
- Root · 6 generations backK915573 Venous Reservoir W/Cardiotomy FilterBaxter Healthcare Corp · 1992
- 5 generations backK982223 Capiox SX Hardshell ResevoirTerumo Medical Corp. · 1998
- 4 generations backK991973 Capiox SX10 Hardshell ResevoirTerumo Medical Corp. · 1999
- 3 generations backK030449 Modification to Capiox SX10 Hardshell ReservoirTerumo Corp. · 2003
- 2 generations backK051997 Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell ReservoirTerumo Cardiovascular Systems Corp. · 2005 · Recalled
- 1 generation backK062381 Capiox RX Oxygenator with or Without ReservoirTerumo Cardiovascular Systems Corp. · 2006 · Recalled
- This deviceK082321 Terumo Rocsafe Hybrid Perfusion SystemTerumo Cardiovascular Systems Corp. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K915573 | Venous Reservoir W/Cardiotomy Filter | Baxter Healthcare Corp | 1992 | — |
| −5 | K982223 | Capiox SX Hardshell Resevoir | Terumo Medical Corp. | 1998 | — |
| −4 | K991973 | Capiox SX10 Hardshell Resevoir | Terumo Medical Corp. | 1999 | — |
| −3 | K030449 | Modification to Capiox SX10 Hardshell Reservoir | Terumo Corp. | 2003 | — |
| −2 | K051997 | Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell Reservoir | Terumo Cardiovascular Systems Corp. | 2005 | 1 |
| −1 | K062381 | Capiox RX Oxygenator with or Without Reservoir | Terumo Cardiovascular Systems Corp. | 2006 | 2 |
| 0 (this device) | K082321 | Terumo Rocsafe Hybrid Perfusion System | Terumo Cardiovascular Systems Corp. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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? (7)
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 |
|---|---|---|---|
| * | K062381 | Capiox RX Oxygenator with or Without ReservoirSummary page 2…ice(s): The device submitted in this 510(k) maintains characteristics that are substantially equivalent to the following devices: · Terumo's Capiox® RX15 Oxygenator- K062381 and K051997 * Terumo's Capiox® RX25 Oxygenator- K062381 and K040210 · Terumo's Capiox® Hardshell Reservoir Filter - K062… | 2006 |
| * | K051997 | Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell ReservoirSummary page 2…device submitted in this 510(k) maintains characteristics that are substantially equivalent to the following devices: · Terumo's Capiox® RX15 Oxygenator- K062381 and K051997 * Terumo's Capiox® RX25 Oxygenator- K062381 and K040210 · Terumo's Capiox® Hardshell Reservoir Filter - K062381 ·… | 2005 |
| * | K040210 | Capiox RX25 Hollow Fiber Oxygenator W/WO Hardshell ReservoirSummary page 2…t are substantially equivalent to the following devices: · Terumo's Capiox® RX15 Oxygenator- K062381 and K051997 * Terumo's Capiox® RX25 Oxygenator- K062381 and K040210 · Terumo's Capiox® Hardshell Reservoir Filter - K062381 · Sarms Centrifugal Pump - K020998 · Terumo's Capiox® AF1… | 2004 |
| * | K020998 | Sarns Centrifugal Pump with Xcoating, Model 164275XSummary page 2…381 and K051997 * Terumo's Capiox® RX25 Oxygenator- K062381 and K040210 · Terumo's Capiox® Hardshell Reservoir Filter - K062381 · Sarms Centrifugal Pump - K020998 · Terumo's Capiox® AF125X Arterial Filter - K052205 · Terumo's CDI Cuvette - K915265 · Medtronic Resting Heart Sy… | 2002 |
| * | K052205 | Capiox AF125X Arterial FilterSummary page 2…062381 and K040210 · Terumo's Capiox® Hardshell Reservoir Filter - K062381 · Sarms Centrifugal Pump - K020998 · Terumo's Capiox® AF125X Arterial Filter - K052205 · Terumo's CDI Cuvette - K915265 · Medtronic Resting Heart System - K031700 Intended Use:… | 2005 |
| * | K915265 | Cdi (TM) H/S Cuvette, ModificationSummary page 2…x® Hardshell Reservoir Filter - K062381 · Sarms Centrifugal Pump - K020998 · Terumo's Capiox® AF125X Arterial Filter - K052205 · Terumo's CDI Cuvette - K915265 · Medtronic Resting Heart System - K031700 Intended Use:… | 1992 |
| * | K031700 | Medtronic Resting Heart System, Model AAR1000 and 711Summary page 2…Sarms Centrifugal Pump - K020998 · Terumo's Capiox® AF125X Arterial Filter - K052205 · Terumo's CDI Cuvette - K915265 · Medtronic Resting Heart System - K031700 Intended Use: 18 === Page… | 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 17 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 8 of the 24 ancestors have a recall of any class.
- 1 other device also cites its predicate K062381.
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. 2009, 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 ROCSafeTM Hybrid Perfusion System is a pre-connected extra-corporeal circuit that is designed to offer circulatory support, blood gas maintenance and blood filtration during cardiopulmonary bypass procedures lasting not more than 6-hours in duration. The ROCSafe may only be used with Terumo's System 1 Heart/Lung Pump Platform. The System includes the following: The Capiox RX Hollow Fiber Oxygenators are intended to be used to exchange gases between…
Read the full statement (367 words)
The ROCSafeTM Hybrid Perfusion System is a pre-connected extra-corporeal circuit that is designed to offer circulatory support, blood gas maintenance and blood filtration during cardiopulmonary bypass procedures lasting not more than 6-hours in duration. The ROCSafe may only be used with Terumo's System 1 Heart/Lung Pump Platform. The System includes the following:
The Capiox RX Hollow Fiber Oxygenators are intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery. The integral heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device. The Capiox RX15 is for use with patients when the required blood flow rate will not exceed 5.0 L/min. The Capiox RX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min. The Oxygenators are intended to be used in cardiopulmonary bypass procedures that do not exceed 6 hours in duration.
The Centrifugal Pump. is indicated as an extracorporeal blood pump for use in cardiopulmonary bypass procedures and is a component of the ROCSafe Hybrid Perfusion System. It is intended to propel blood through the cardiopulmonary bypass circuit. The centrifugal pump is intended to be used in cardioDUlmonary bypass procedures that do not exceed 6_hours in duration.
The Capiox AF 125X Arterial Line Blood Filter is intended to filter non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit for up to 6 hours. The Arterial Filter is intended to be used in cardiopulmonary bypass procedures that do not exceed 6 hours in duration.
The Capiox Venous Bubble Trap is intended to facilitate the removal of air and bubbles from incoming venous blood as it flows into the extra-corporeal bypass circuit. The Bubble Trap is intended to be used in cardiopulmonary bypass procedures that. do not exceed 6 hours in duration.
The CDI Cuvette is intended for use with the CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematbcrit, hemoglobin and oxygen saturation is desired. The Cuvettes are intended to be used in cardiopulmonary bypass procedures that do not exceed 6 hours in duration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082321: Terumo Rocsafe Hybrid Perfusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082321
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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