510(k) · Cleared
ClearedGish Arterial Filter with HA Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gish Biomedical, Inc. · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Cleared on Jan 15, 2009 as substantially equivalent to K914791 (Gish Biomedical, Inc., 1993) and 1 other predicate after a 276-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Jan 15, 2009
- Review
- 276 days
- Class
- Class II
- Product code
- DTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K914791 (1993). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 DTM? 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 DTM device
- #1 K251744 Affinity Pixie™ Arterial Filter with Balance™…score 11.0 · 2 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 |
|---|---|---|---|
| * | K914791 | Gish Arterial FilterSummary page 1…sification Name: Arterial Line Blood Filter, Cardiopulmonary Bypass 3. Predicate Devices: Gish Arterial Filter, Gish Biomedical, Inc., K914791 and Gish Arterial Filter with GBS TM Coating, K023833. Both manufactured by Gish Biomedical, Inc. 4. Clas… | 1993 |
| * | K023833 | Gish Arterial Filter with GBS CoatingSummary page 1…ary Bypass 3. Predicate Devices: Gish Arterial Filter, Gish Biomedical, Inc., K914791 and Gish Arterial Filter with GBS TM Coating, K023833. Both manufactured by Gish Biomedical, Inc. 4. Classifications Names & Citations: 21 CFR 870.4260, Arteri… | 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 16 years and passes through 1 company; a new generation was cleared every 10.0 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K914791.
How does its category compare?
All DTM devicesDTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DTM
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DTM
246in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTM
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTM
4in 2024
MAUDE reports naming product code DTM, 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 | 3 | 60 | 0 | 8 |
| 2008 | 1 | — | 1 | 2 |
| 2009 | 5 | 246 | 0 | 0 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 8 |
| 2012 | 2 | — | 0 | 6 |
| 2013 | 1 | — | 0 | 9 |
| 2014 | 0 | — | 0 | 64 |
| 2015 | 0 | — | 0 | 34 |
| 2016 | 0 | — | 0 | 27 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 0 | — | 1 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Arterial Filter with HA Coating is indicated for use for up to 6 hours in the extracorporeal bypass circuit for the removal of microemboli.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081054: Gish Arterial Filter with HA Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081054
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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