510(k) · Cleared
Recalled · 2005Vision Hollow Fiber Oxygenator with Guardian 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 Mar 31, 2003 as substantially equivalent to K961530 (Gish Biomedical, Inc., 1996) after a 174-day review. Its family tree reaches back 2 generations to 1992. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 31, 2003
- Review
- 174 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922933 (1992). 3 ancestors in all. 2 later devices descend from it, 2 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 deviceK023381 Vision Hollow Fiber Oxygenator with Guardian CoatingGish Biomedical, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK080708 Vision Hollow Fiber Oxygenator with HA CoatingGish Biomedical, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK031300 Ibc Flopump with GBS CoatingGish Biomedical, Inc. · 2003
Most influential descendants
Showing 2 of 2 · See allView 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) | K023381 | Vision Hollow Fiber Oxygenator with Guardian Coating | Gish Biomedical, Inc. | 2003 | — |
| +1 | K080708 | Vision Hollow Fiber Oxygenator with HA Coating | Gish Biomedical, Inc. | 2009 | — |
| +1 | K031300 | Ibc Flopump with GBS Coating | Gish Biomedical, Inc. | 2003 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K961530 | Gish Reliance Oxygenator (Model Hfo)Summary page 1…Classification Name: Oxygenator, Cardiopulmonary Bypass 3. Predicate Devices: Vision Hollow Fiber Oxygenator, Gish Biomedical, Inc., K961530. 4. Classifications Names & Citations: 21 CFR 870.4350, Oxygenator, Cardiopulmonary Bypass, Class II, DTZ,… | 1996 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 28, 2005 | Not classified | Z-0519-06 | Other | Gish received four reports of potential leakage. All reports were associated with GBS coating. There was no patient injury reported. |
| Mar 4, 2004 | Not classified | Z-0730-04 | Other | Customers reported leakage. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K080708 (Gish Biomedical, Inc., 2009) has gone furthest, with 0 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.
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 GuardianTMCoating 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.O) 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/K023381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023381: Vision Hollow Fiber Oxygenator with Guardian Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023381
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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