510(k) · Cleared
ClearedMedos Hilite Oxygenator, Model 7000 & 7000 LT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gish Biomedical, Inc. · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on May 15, 2009 as substantially equivalent to K961530 (Gish Biomedical, Inc., 1996) after a 267-day review. Its family tree reaches back 2 generations to 1992. 6 later devices descend from it.
- Decided
- May 15, 2009
- Review
- 267 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922933 (1992). 3 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 1 generation backK961530 Gish Reliance Oxygenator (Model Hfo)Gish Biomedical, Inc. · 1996 · Recalled
- This deviceK082403 Medos Hilite Oxygenator, Model 7000 & 7000 LTGish Biomedical, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK133261 Medos Hilite 7000 & 7000 LT OxygenatorMedos Medizintechnik AG · 2014
- Descendant · 2 generations on · 3 of its ownK191407 Novalung SystemFresenius Medical Care Renal Therapies Group, LLC · 2020 · Recalled
- Descendant · 3 generations on · 1 of its ownK240880 VitalFlow Set with Balance BiosurfaceMedtronic, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK261335 VitalFlow Set with Balance™ BiosurfaceMedtronic, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK253838 Lifemotion Disposable Membrane OxygenatorLifemotion Medical Technology Co., Ltd. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K133261Medos Hilite 7000 & 7000 LT OxygenatorMedos Medizintechnik AG · 2014 · cites it directly5descendants
- K191407Novalung SystemFresenius Medical Care Renal Therapies Group, LLC · 2020 · 2 generations on3descendants
- K240880VitalFlow Set with Balance BiosurfaceMedtronic, Inc. · 2024 · 3 generations on1descendant
- K261335VitalFlow Set with Balance™ BiosurfaceMedtronic, Inc. · 2026 · 4 generations on0descendants
- K253838Lifemotion Disposable Membrane OxygenatorLifemotion Medical Technology Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −1 | K961530 | Gish Reliance Oxygenator (Model Hfo) | Gish Biomedical, Inc. | 1996 | 1 |
| 0 (this device) | K082403 | Medos Hilite Oxygenator, Model 7000 & 7000 LT | Gish Biomedical, Inc. | 2009 | — |
| +1 | K133261 | Medos Hilite 7000 & 7000 LT Oxygenator | Medos Medizintechnik AG | 2014 | — |
| +2 | K191407 | Novalung System | Fresenius Medical Care Renal Therapies Group, LLC | 2020 | 2 |
| +3 | K240880 | VitalFlow Set with Balance Biosurface | Medtronic, Inc. | 2024 | — |
| +4 | K261335 | VitalFlow Set with Balance™ Biosurface | Medtronic, Inc. | 2026 | — |
| +2 | K253838 | Lifemotion Disposable Membrane Oxygenator | Lifemotion Medical Technology Co., Ltd. | 2026 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K961530 | Gish Reliance Oxygenator (Model Hfo)Summary page 1…ommon Name: Blood Oxygenator Classification Name: Oxygenator, Cardiopulmonary Bypass 3. Predicate Devices: Vision Hollow Fiber Oxygenator, K961530, Manufactured by GISH Biomedical, Inc. 4. Classifications Names & Citations: 21 CFR 870.4350, Oxygenator, Cardiopulmona… | 1996 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133261 | Medos Hilite 7000 & 7000 LT Oxygenator | 2014 | 5 |
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 2 companies; a new generation was cleared every 12.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K133261 (Medos Medizintechnik AG, 2014) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K961530.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 LT Hollow 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/K082403 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082403: Medos Hilite Oxygenator, Model 7000 & 7000 LT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082403
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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