510(k) · Cleared
ClearedMedos Hilite 7000 & 7000 LT Oxygenator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos Medizintechnik AG · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Jan 9, 2014 as substantially equivalent to K082403 (Gish Biomedical, Inc., 2009) after a 78-day review. Its family tree reaches back 3 generations to 1992. 5 later devices descend from it.
- Decided
- Jan 9, 2014
- Review
- 78 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922933 (1992). 4 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 2 generations backK961530 Gish Reliance Oxygenator (Model Hfo)Gish Biomedical, Inc. · 1996 · Recalled
- 1 generation backK082403 Medos Hilite Oxygenator, Model 7000 & 7000 LTGish Biomedical, Inc. · 2009
- This deviceK133261 Medos Hilite 7000 & 7000 LT OxygenatorMedos Medizintechnik AG · 2014
- Descendant · cites it directly · 3 of its ownK191407 Novalung SystemFresenius Medical Care Renal Therapies Group, LLC · 2020 · Recalled
- Descendant · 2 generations on · 1 of its ownK240880 VitalFlow Set with Balance BiosurfaceMedtronic, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK261335 VitalFlow Set with Balance™ BiosurfaceMedtronic, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253838 Lifemotion Disposable Membrane OxygenatorLifemotion Medical Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK232926 Novalung ultimate kit (US)Fresenius Medical Care Renal Therapies Group, LLC · 2024
Most influential descendants
Showing 5 of 5 · See all- K191407Novalung SystemFresenius Medical Care Renal Therapies Group, LLC · 2020 · cites it directly3descendants
- K240880VitalFlow Set with Balance BiosurfaceMedtronic, Inc. · 2024 · 2 generations on1descendant
- K261335VitalFlow Set with Balance™ BiosurfaceMedtronic, Inc. · 2026 · 3 generations on0descendants
- K253838Lifemotion Disposable Membrane OxygenatorLifemotion Medical Technology Co., Ltd. · 2026 · cites it directly0descendants
- K232926Novalung ultimate kit (US)Fresenius Medical Care Renal Therapies Group, LLC · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −2 | K961530 | Gish Reliance Oxygenator (Model Hfo) | Gish Biomedical, Inc. | 1996 | 1 |
| −1 | K082403 | Medos Hilite Oxygenator, Model 7000 & 7000 LT | Gish Biomedical, Inc. | 2009 | — |
| 0 (this device) | K133261 | Medos Hilite 7000 & 7000 LT Oxygenator | Medos Medizintechnik AG | 2014 | — |
| +1 | K191407 | Novalung System | Fresenius Medical Care Renal Therapies Group, LLC | 2020 | 2 |
| +2 | K240880 | VitalFlow Set with Balance Biosurface | Medtronic, Inc. | 2024 | — |
| +3 | K261335 | VitalFlow Set with Balance™ Biosurface | Medtronic, Inc. | 2026 | — |
| +1 | K253838 | Lifemotion Disposable Membrane Oxygenator | Lifemotion Medical Technology Co., Ltd. | 2026 | — |
| +2 | K232926 | Novalung ultimate kit (US) | Fresenius Medical Care Renal Therapies Group, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K082403 | Medos Hilite Oxygenator, Model 7000 & 7000 LT Our reading of the summary gave K086403, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Medos Hilite 7000 & 7000 LT Oxygenator”. | 2009 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K191407 (Fresenius Medical Care Renal Therapies Group, LLC, 2020) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 MEDOS HILITE 7000 & 7000 IT Hallow Fiber Oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of one (1 .0) to seven (7.0) liters per minute for periods of up to six (6.0) hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133261: Medos Hilite 7000 & 7000 LT Oxygenator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133261
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