510(k) · Cleared
ClearedCentury Perfusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Century Hlm, LLC · DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Cleared on Mar 7, 2021 as substantially equivalent to K060053 (Sorin Group Deutschland GmbH, 2006) and 1 other predicate after a 219-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Mar 7, 2021
- Review
- 219 days
- Class
- Class II
- Product code
- DTQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K960974 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK960974 Cobe Century Perfusion PumpCobe Cardiovascular, Inc. · 1997
- This deviceK202125 Century Perfusion SystemCentury Hlm, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960974 | Cobe Century Perfusion Pump | Cobe Cardiovascular, Inc. | 1997 | — |
| 0 (this device) | K202125 | Century Perfusion System | Century Hlm, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 DTQ? 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 DTQ device
- #1 K221373 Essenz HLMscore 8.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K060053 | Stockert S5 SystemSummary page 5…DTQ Regulatory Class: Class II Information for the 510(k) Cleared Device (Predicate Device): Stöckert S5 System (K060053) currently marketed by LivaNova Page 1 of 27 Information for the 510(k) Cleared Device (Reference Predicate D… | 2006 |
| * | K960974 | Cobe Century Perfusion PumpSummary page 6…rently marketed by LivaNova Page 1 of 27 Information for the 510(k) Cleared Device (Reference Predicate Device): Cobe Century Perfusion Pump (K960974) currently marketed by Century HLM, LLC (Submitter). Device Description: The Century Perfusion System is a modular sys… | 1997 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K060053.
How does its category compare?
All DTQ devicesDTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DTQ
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DTQ
292in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTQ
1in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DTQ
1,014in 2025
MAUDE reports naming product code DTQ, 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 | 2 | — | 9 | 420 |
| 2008 | 1 | — | 17 | 548 |
| 2009 | 3 | 86 | 1 | 589 |
| 2010 | 1 | — | 17 | 811 |
| 2011 | 2 | — | 22 | 1,081 |
| 2012 | 0 | — | 42 | 1,626 |
| 2013 | 0 | — | 4 | 906 |
| 2014 | 2 | — | 1 | 1,290 |
| 2015 | 2 | — | 0 | 1,184 |
| 2016 | 0 | — | 0 | 714 |
| 2017 | 2 | — | 0 | 527 |
| 2018 | 1 | — | 1 | 676 |
| 2019 | 1 | — | 1 (1) | 857 |
| 2020 | 0 | — | 0 | 627 |
| 2021 | 2 | — | 0 | 729 |
| 2022 | 0 | — | 1 | 717 |
| 2023 | 3 | 292 | 7 (1) | 818 |
| 2024 | 0 | — | 1 | 863 |
| 2025 | 0 | — | 0 | 1,014 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Century Perfusion System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202125 · printed Nov 4, 2026
Cite this page
510(k) Report. “K202125: Century Perfusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K202125
Report an extraction error
Are you the manufacturer?
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