510(k) · Cleared
ClearedGish ATR2900 and CAP35 Series Reservoirs with GBS Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gish Biomedical, Inc. · DTN Reservoir, Blood, Cardiopulmonary Bypass
Cleared on Aug 12, 2005 after a 57-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 12, 2005
- Review
- 57 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 DTN? 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 DTN device
- #1 K251783 Inspire HCR and HCR DUAL cardiotomy reservoirsscore 12.4 · 7 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 |
|---|---|---|---|
| * | — | Gish ATR2900DF Reservoir Named without a submission number | |
| * | — | Gish 35DF Reservoir Named without a submission number |
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.
How does its category compare?
All DTN devicesDTN Reservoir, Blood, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTN
38in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTN
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTN
8in 2025
MAUDE reports naming product code DTN, 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 | 2 | — | 1 | 10 |
| 2008 | 1 | — | 1 | 8 |
| 2009 | 7 | 211 | 1 | 10 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 2 | — | 1 | 10 |
| 2012 | 0 | — | 0 | 17 |
| 2013 | 4 | 79 | 0 | 47 |
| 2014 | 3 | 38 | 0 | 52 |
| 2015 | 2 | — | 0 | 27 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 2 | — | 1 | 3 |
| 2018 | 0 | — | 2 | 4 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 2 | — | 0 | 10 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Gish ATR2900 Series Reservoirs with GBS TM Coating are indicated for use: 1. During cardiopulmonary bypass surgery to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit. 2. During general surgery procedures other than cardiopulmonary bypass, for collection and filtration of suctioned blood. During these procedures, the reservoir must be used in conjunction with appropriate cell-washing techniques. 3.…
Read the full statement (266 words)
The Gish ATR2900 Series Reservoirs with GBS TM Coating are indicated for use:
1. During cardiopulmonary bypass surgery to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit.
2. During general surgery procedures other than cardiopulmonary bypass, for collection and filtration of suctioned blood. During these procedures, the reservoir must be used in conjunction with appropriate cell-washing techniques.
3. Once intraoperative use is completed, for the collection and autotransfusion of the same patients post operative blood using components available separately in the SVP400 or SVP450 STAT-VAC Conversion Pack, ATR200 or ATR250 Supplemental Drainage Set, ATR500 Wound drainage Postoperative Pack or ATR600 Supplemental Wound Drainage Line Set.
4. With or without a water seal when used for postoperative autotransfusion, depending on user preference and application. The SVP400, SVP450 and STAT-VAC provide a water seal for use with ATR2900. The attending physician is solely responsible for the decision to use or not to use a water seal..
The Gish CAP35 Series Reservoirs with GBS TM Coating with integral water seal/water manometer are indicated for use during cardiopulmonary bypass surgery to filter/defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit. The CAP35 Series Reservoirs are indicated for the collection and autotransfusion of the same patients postoperative shed blood, using components available separately in the CAP400 or CAP450 Postoperative Conversion Pack and ATR200 or ATR250 Supplemental Drainage Set.
The Gish CAP400/450 Pack is indicated for use exclusively with the Gish CAP Series Products: The Gish CAP400/450 Pack provides components used to convert the Gish CAP systems from intraoperative to post operative use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051606 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051606: Gish ATR2900 and CAP35 Series Reservoirs with GBS Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051606
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026