510(k) · Cleared
ClearedMedos Hilite Infant 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 Feb 19, 2014 as substantially equivalent to K090449 (Gish Biomedical, Inc., 2009) after a 26-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Feb 19, 2014
- Review
- 26 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K842908 (1985). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK842908 Variable Prime Cobe Membrane LungCobe Laboratories, Inc. · 1985
- 2 generations backK022115 Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell ReservoirTerumo Corp. · 2002
- 1 generation backK090449 Medos Hilite Infant Oxygenator, Model 1000, 800 LTGish Biomedical, Inc. · 2009
- This deviceK140181 Medos Hilite Infant OxygenatorMedos Medizintechnik AG · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K842908 | Variable Prime Cobe Membrane Lung | Cobe Laboratories, Inc. | 1985 | — |
| −2 | K022115 | Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell Reservoir | Terumo Corp. | 2002 | — |
| −1 | K090449 | Medos Hilite Infant Oxygenator, Model 1000, 800 LT | Gish Biomedical, Inc. | 2009 | — |
| 0 (this device) | K140181 | Medos Hilite Infant Oxygenator | Medos Medizintechnik AG | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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? (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 |
|---|---|---|---|
| * | K090449 | Medos Hilite Infant Oxygenator, Model 1000, 800 LTSummary page 1…ation Name: Oxygenator, Cardiopulmonary Bypass Classification regulation: Sec. 870.4350 VI. PRODUCT CODES: DTZ VII. PREDICATE DEVICES K090449, Medos Hilite Infant Oxygenator, Model 1000 &800 LT Oxygenator Vill. PRODUCT DESCRIPTION Medos Medizintechnik AG, Special 51… | 2009 |
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 29 years and passes through 4 companies; a new generation was cleared every 7.0 years on median.
- None of the 4 ancestors has a recall.
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 1000 & 800 LT Infant Hollow Fiber Oxygenators are 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 200 mI/mmn (0.2 liters/minute) to iQO0mI/min (1.0 liters per minute) for the Hilite 1000 and 200 mI/mmn (0.2 liters/minute) to 800 mI/mmn (0.8 liters per minute) for the Hilite 800 LT for periods of up to six (6.0) hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140181: Medos Hilite Infant Oxygenator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140181
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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