510(k) · Cleared
ClearedBW685, BW685S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biegler GmbH · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Jul 12, 2012 as substantially equivalent to K954769 (Biegler Medical Products, Inc., 1996) after an 84-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Jul 12, 2012
- Review
- 84 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954769 (1996). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K213191S-LineBarkey GmbH & Co. KG · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954769 | Biegler BW385L Blood & Infusion Warmer | Biegler Medical Products, Inc. | 1996 | — |
| 0 (this device) | K121198 | BW685, BW685S | Biegler GmbH | 2012 | — |
| +1 | K213191 | S-Line | Barkey GmbH & Co. KG | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (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 |
|---|---|---|---|
| * | K954769 | Biegler BW385L Blood & Infusion WarmerSummary page 1…/Usual Name: Fluid Wanner Classification Name: Warmer, thennal. infusion fluid Predicate Devices: Biegler BW385L K954769 Device Description: The BW685 and BW685S are blood and infusion flid warmers designed to reduce complications associated with th… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213191 | S-Line | 2022 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K213191 (Barkey GmbH & Co. KG, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LGZ devicesLGZ Warmer, Thermal, Infusion Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
The BW685/BW685 S blood / fluid warming system is intended to deliver warm blood,
blood products, and liquids to adult and pediatric patients.
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/K121198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121198: BW685, BW685S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121198
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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