510(k) · Cleared
ClearedMedos Hilite Infant Oxygenator, Model 1000, 800 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 Sep 18, 2009 as substantially equivalent to K022115 (Terumo Corp., 2002) after a 210-day review. Its family tree reaches back 2 generations to 1985. 1 later device descends from it.
- Decided
- Sep 18, 2009
- Review
- 210 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K842908 (1985). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK842908 Variable Prime Cobe Membrane LungCobe Laboratories, Inc. · 1985
- 1 generation backK022115 Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell ReservoirTerumo Corp. · 2002
- This deviceK090449 Medos Hilite Infant Oxygenator, Model 1000, 800 LTGish Biomedical, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK140181 Medos Hilite Infant OxygenatorMedos Medizintechnik AG · 2014
Most influential descendants
Showing 1 of 1 · See all- K140181Medos Hilite Infant OxygenatorMedos Medizintechnik AG · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K842908 | Variable Prime Cobe Membrane Lung | Cobe Laboratories, Inc. | 1985 | — |
| −1 | K022115 | Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell Reservoir | Terumo Corp. | 2002 | — |
| 0 (this device) | K090449 | Medos Hilite Infant Oxygenator, Model 1000, 800 LT | Gish Biomedical, Inc. | 2009 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K022115 | Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell ReservoirSummary page 1…Classification Name: Oxygenator, Cardiopulmonary Bypass 3. Predicate Devices: CAPIOX® RX05 Hollow Fiber Oxygenator, K022115, Manufactured by Terumo 4. Classifications Names & Citations: 21 CFR 870.4350, Oxygenator,… | 2002 |
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 |
|---|---|---|---|
| K140181 | Medos Hilite Infant Oxygenator | 2014 | 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 24 years and passes through 3 companies; a new generation was cleared every 17.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K140181 (Medos Medizintechnik AG, 2014) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K022115.
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 1000 & 800 LT Hollow Fiber Oxygenators are indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. The 1000 & 800 LT are neonate, infant oxygenators intended for use at blood flow rates of 0.2 to 1.0 liters per minute for the HILITE 1000 and 0.2 to 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/K090449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090449: Medos Hilite Infant Oxygenator, Model 1000, 800 LT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090449
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