510(k) · Cleared
ClearedFresenius ATR40 and ATR120 Autotransfusion Reservoirs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Hemotechnology, Inc. · DTN Reservoir, Blood, Cardiopulmonary Bypass
Cleared on Jun 29, 1999 as substantially equivalent to K802674 (Haemonetics Corp., 1981) and 1 other predicate after a 187-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- Jun 29, 1999
- Review
- 187 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K802674 (1981). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK802674 Reservoir for Autologous Blood Transfus.Haemonetics Corp. · 1981
- This deviceK984586 Fresenius ATR40 and ATR120 Autotransfusion ReservoirsFresenius Hemotechnology, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K802674 | Reservoir for Autologous Blood Transfus. | Haemonetics Corp. | 1981 | — |
| 0 (this device) | K984586 | Fresenius ATR40 and ATR120 Autotransfusion Reservoirs | Fresenius Hemotechnology, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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 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 |
|---|---|---|---|
| * | K802674 | Reservoir for Autologous Blood Transfus.Summary page 2…tion Name: Autotransfusion Blood Collection Reservoir Legally Marketed Devices to which substantial equivalence is claimed: Haemonetics Cell Saver Collection Reservoir (K802674) Medtronic EL240 Blood Collection Reservoir (K915737 Intended Use: The Fresenius ATR 40 and ATR Autotransfusion Reservoirs are… | 1981 |
| * | K915737 | Autotransfusion Blood Collection ReservoirSummary page 2…Legally Marketed Devices to which substantial equivalence is claimed: Haemonetics Cell Saver Collection Reservoir (K802674) Medtronic EL240 Blood Collection Reservoir (K915737 Intended Use: The Fresenius ATR 40 and ATR Autotransfusion Reservoirs are intended for use as autotransfusion reservoirs to coll… | 1992 |
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?
- None of the 2 ancestors has a 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 ATR 40 and ATR 120 Autotransfusion Reservoirs are indicated as autotransfusion reservoirs to collect defoam, filter, and store blood prior to processing.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984586 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984586: Fresenius ATR40 and ATR120 Autotransfusion Reservoirs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984586
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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