510(k) · Cleared
ClearedAstoflo Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stihler Electronic GmbH · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Dec 18, 2008 as substantially equivalent to K020060 (Nats Corp., 2002) and 1 other predicate after an 87-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Dec 18, 2008
- Review
- 87 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K020103 (2002). 3 ancestors in all, the oldest K020060 (2002). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020103 | Prismaflo | Stihler Electronic GmbH | 2002 | — |
| −1 | K071909 | Prismacomfort, Model Autocontrol 3XPT with Autoline XPT 4R | Barkey GmbH & Co. KG | 2007 | — |
| 0 (this device) | K082765 | Astoflo Plus | Stihler Electronic GmbH | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 LGZ? 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 LGZ device
- #1 K260988 °M Warmer System with °M Stationscore 12.7 · 6 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 |
|---|---|---|---|
| * | K020060 | AstofloSummary page 1…BSB Regulation: (864.9205) Warmer, Thermal, Infusion Fluid Warmer, Blood, Non-Electromagnetic PREDICATE DEVICES: Stihler Electronic GmbH, Blood Warmer Model ASTOFLO - K020060 Barkey GmbH + Co. KG, Blood Warmer Mode! Prismacomfort — K071909 DESCRIPTION: The ASTOFLO PLUS is a modified version of the AST… | 2002 |
| * | K071909 | Prismacomfort, Model Autocontrol 3XPT with Autoline XPT 4RSummary page 1…r, Blood, Non-Electromagnetic PREDICATE DEVICES: Stihler Electronic GmbH, Blood Warmer Model ASTOFLO - K020060 Barkey GmbH + Co. KG, Blood Warmer Mode! Prismacomfort — K071909 DESCRIPTION: The ASTOFLO PLUS is a modified version of the ASTOFLO covered by K020060. The ASTOFLO uses the closed water circui… | 2007 |
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 6 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All LGZ devicesLGZ Warmer, Thermal, Infusion Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LGZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LGZ
546in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LGZ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LGZ
376in 2025
MAUDE reports naming product code LGZ, 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 | — | 0 | 11 |
| 2008 | 4 | 99 | 0 | 10 |
| 2009 | 2 | — | 1 | 12 |
| 2010 | 2 | — | 1 | 43 |
| 2011 | 3 | 77 | 8 | 54 |
| 2012 | 7 | 162 | 0 | 52 |
| 2013 | 5 | 143 | 0 | 16 |
| 2014 | 0 | — | 0 | 23 |
| 2015 | 2 | — | 1 | 34 |
| 2016 | 2 | — | 1 | 15 |
| 2017 | 2 | — | 0 | 58 |
| 2018 | 1 | — | 0 | 94 |
| 2019 | 3 | 209 | 0 | 340 |
| 2020 | 0 | — | 0 | 1,221 |
| 2021 | 0 | — | 0 | 885 |
| 2022 | 3 | 546 | 0 | 1,548 |
| 2023 | 1 | — | 0 | 1,033 |
| 2024 | 1 | — | 0 | 862 |
| 2025 | 2 | — | 0 | 376 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
1. Warming transfusions, infusions, fluids.
2. Warming blood transfusions and return blood flow.
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/K082765 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082765: Astoflo Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082765
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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