510(k) · Cleared
ClearedFluido® AirGuard System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Surgical Company International BV (As Tsc Life) · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Sep 4, 2025 as substantially equivalent to K141654 (Belmont Instrument Corporation, 2014) after a 90-day review. Its family tree reaches back 4 generations to 1985.
- Decided
- Sep 4, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K852645 (1985). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK852645 Fluid Management SystemHaemonetics Corp. · 1985
- 3 generations backK972284 Fluid Management SystemBelmont Instrument Corp. · 1997 · Recalled
- 2 generations backK032674 Belmont Fluid Management System, Model FMS2000Belmont Instrument Corp. · 2003 · Recalled
- 1 generation backK141654 The Belmont Rapid InfuserBelmont Instrument Corporation · 2014
- This deviceK251733 Fluido® AirGuard SystemThe Surgical Company International BV (As Tsc Life) · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K852645 | Fluid Management System | Haemonetics Corp. | 1985 | — |
| −3 | K972284 | Fluid Management System | Belmont Instrument Corp. | 1997 | 1 |
| −2 | K032674 | Belmont Fluid Management System, Model FMS2000 | Belmont Instrument Corp. | 2003 | 1 |
| −1 | K141654 | The Belmont Rapid Infuser | Belmont Instrument Corporation | 2014 | — |
| 0 (this device) | K251733 | Fluido® AirGuard System | The Surgical Company International BV (As Tsc Life) | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | K141654 | The Belmont Rapid InfuserSummary page 6…fusion Pump Classification Name: Infusion Pump, 21 CFR 880.5725 Regulatory Class: Il Product Code: LGZ Name of Predicate: The Belmont® Rapid Infuser, RI2 510k Number: K141654 This predicate has not been subject to a design-related recall. Name of Reference Device: Ranger Irrigation Fluid Warming System… | 2014 |
| † | K060939 | Ranger Irrigation Fluid Warming System | 2006 |
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 40 years and passes through 4 companies; a new generation was cleared every 11.1 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K141654.
How does its category compare?
All LGZ devicesLGZ Warmer, Thermal, Infusion Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Infusion of crystalloid, colloid or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery.
Infusion of warmed fluid to patients with the ability to prevent hypothermia.
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/K251733 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251733: Fluido® AirGuard System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251733
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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