510(k) · Cleared
ClearedParagon Adult Maxi PMP Oxygenator with Tubing Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chalice Medical, Ltd. · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Sep 18, 2020 as substantially equivalent to K122254 (Sorin Group Italia S.R.L., 2012) and 1 other predicate after a 93-day review. Its family tree reaches back 6 generations to 1992. 1 later device descends from it.
- Decided
- Sep 18, 2020
- Review
- 93 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K922933 (1992). 9 ancestors in all, the oldest K771692 (1977). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 5 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 4 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- 3 generations backK033323 D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2…Dideco S.P.A. · 2004 · Recalled
- 2 generations backK121229 Inspire 8 Dual Hollow Fiber Oxygenator with with Integrated…Sorin Group Italia S.R.L. · 2012
- 1 generation backK122254 Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell…Sorin Group Italia S.R.L. · 2012
- This deviceK201642 Paragon Adult Maxi PMP Oxygenator with Tubing PackChalice Medical, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK231414 CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)Chalice Medical, Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K231414CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)Chalice Medical, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −5 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −4 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| −3 | K033323 | D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 PH.I.S.I.O. Adult… | Dideco S.P.A. | 2004 | 1 |
| −2 | K121229 | Inspire 8 Dual Hollow Fiber Oxygenator with with Integrated Hardshell… | Sorin Group Italia S.R.L. | 2012 | — |
| −1 | K122254 | Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy… | Sorin Group Italia S.R.L. | 2012 | — |
| 0 (this device) | K201642 | Paragon Adult Maxi PMP Oxygenator with Tubing Pack | Chalice Medical, Ltd. | 2020 | — |
| +1 | K231414 | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) | Chalice Medical, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 2001 | 2 | 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.
Planning a device in DTZ? 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 DTZ device
- #1 K240934 Quantum Perfusion Blood Oxygenator ECC…score 14.3 · 12 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 |
|---|---|---|---|
| * | K122254 | Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy ReservoirSummary page 4…DTR, DWF Regulatory Class II Class: 510(k) Review Cardiovascular Panel Predicate Sorin Group Italia Inspire 8M (K122254) - Primary Device(s) COBE Laboratories Tubing Sets (K771692) FDA K201642 Clearance Para… | 2012 |
| * | K771692 | Tubing SetsSummary page 4…Cardiovascular Panel Predicate Sorin Group Italia Inspire 8M (K122254) - Primary Device(s) COBE Laboratories Tubing Sets (K771692) FDA K201642 Clearance Paragon Adult Maxi PMP Oxygenator with Tubing Pack: Section 5 Page: 5-1 (Page 1… | 1977 |
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 |
|---|---|---|---|
| K231414 | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) | 2023 | 0 |
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 28 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K231414 (Chalice Medical, Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K122254.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · DTZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTZ
124in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTZ
1in 2025
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DTZ
976in 2025
MAUDE reports naming product code DTZ, 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 | 4 | 55 | 7 | 134 |
| 2008 | 3 | 88 | 5 | 105 |
| 2009 | 9 | 210 | 0 | 52 |
| 2010 | 2 | — | 1 | 119 |
| 2011 | 4 | 160 | 13 | 190 |
| 2012 | 9 | 90 | 14 | 215 |
| 2013 | 9 | 28 | 0 | 346 |
| 2014 | 5 | 28 | 2 | 764 |
| 2015 | 9 | 134 | 0 | 658 |
| 2016 | 3 | 62 | 1 | 443 |
| 2017 | 2 | — | 0 | 388 |
| 2018 | 3 | 72 | 2 (2) | 320 |
| 2019 | 5 | 90 | 1 | 489 |
| 2020 | 5 | 93 | 3 | 442 |
| 2021 | 5 | 336 | 1 (1) | 595 |
| 2022 | 2 | — | 6 | 559 |
| 2023 | 5 | 145 | 0 | 738 |
| 2024 | 3 | 124 | 0 | 535 |
| 2025 | 2 | — | 1 | 976 |
| 2026 | 3 | 137 | 0 | — |
What is it indicated for?
The Paragon Adult Maxi PMP Oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardiopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature. The Paragon Adult Maxi PMP Oxygenator is intended for clinical use for up to 6 hours.
The Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201642: Paragon Adult Maxi PMP Oxygenator with Tubing Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201642
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