510(k) · Cleared
ClearedVision Hollow Fiber Oxygenator with HA Coating
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 Feb 2, 2009 as substantially equivalent to K961530 (Gish Biomedical, Inc., 1996) and 1 other predicate after a 327-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Feb 2, 2009
- Review
- 327 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K922933 (1992). 4 ancestors in all. No later device cites it as a predicate yet.
- 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 backK023381 Vision Hollow Fiber Oxygenator with Guardian CoatingGish Biomedical, Inc. · 2003 · Recalled
- This deviceK080708 Vision Hollow Fiber Oxygenator with HA CoatingGish Biomedical, Inc. · 2009
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 | K023381 | Vision Hollow Fiber Oxygenator with Guardian Coating | Gish Biomedical, Inc. | 2003 | 2 |
| 0 (this device) | K080708 | Vision Hollow Fiber Oxygenator with HA Coating | Gish Biomedical, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 |
|---|---|---|---|
| * | K961530 | Gish Reliance Oxygenator (Model Hfo)Summary page 1…Blood Oxygenator Classification Name: Oxygenator, Cardiopulmonary Bypass 3. Predicate Devices: Vision Hollow Fiber Oxygenator, K961 530 and Vision Hollow Fiber Oxygenator with Guardian Coat, K023381. Both, manufactured by Gish Biomedical, Inc. 4. Cl… | 1996 |
| * | K023381 | Vision Hollow Fiber Oxygenator with Guardian CoatingSummary page 1…Cardiopulmonary Bypass 3. Predicate Devices: Vision Hollow Fiber Oxygenator, K961 530 and Vision Hollow Fiber Oxygenator with Guardian Coat, K023381. Both, manufactured by Gish Biomedical, Inc. 4. Classifications Names & Citations: 21 CFR 870.4350, Oxygenator, C… | 2003 |
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 17 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 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 Vision Hollow Fiber Oxygenator with HA Coating 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 eight (8.0) 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/K080708 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080708: Vision Hollow Fiber Oxygenator with HA Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080708
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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