510(k) · Cleared
ClearedFluido Compact System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Surgical Company International B.V. · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Nov 18, 2025 as substantially equivalent to K211618 (The Surgical Company International B.V., 2023) after a 90-day review. Its family tree reaches back 6 generations to 1977. 2 of the 9 devices in its family, counting itself, have a Class I recall.
- Decided
- Nov 18, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K770232 (1977). 8 ancestors in all. No later device cites it as a predicate yet. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK770232 Blood/Fluid Warmer Model DW-1000AGorman Rupp Industries · 1977
- 5 generations backK984640 Thermal AngelEstill Medical Technologies, Inc. · 1999 · Recalled
- 4 generations backK012031 Modification to Thermal AngelEstill Medical Technologies, Inc. · 2001 · Recalled
- 3 generations backK060537 Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model…Enginivity, LLC · 2006 · Recalled (Class I)
- 2 generations backK112902 Enflow IV Fluid WarmerVital Signs, Inc. · 2012
- 1 generation backK211618 Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V. · 2023
- This deviceK252636 Fluido Compact SystemThe Surgical Company International B.V. · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K770232 | Blood/Fluid Warmer Model DW-1000A | Gorman Rupp Industries | 1977 | — |
| −5 | K984640 | Thermal Angel | Estill Medical Technologies, Inc. | 1999 | 1 |
| −4 | K012031 | Modification to Thermal Angel | Estill Medical Technologies, Inc. | 2001 | 1 |
| −3 | K060537 | Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and… | Enginivity, LLC | 2006 | Class I |
| −2 | K112902 | Enflow IV Fluid Warmer | Vital Signs, Inc. | 2012 | — |
| −1 | K211618 | Fluido Compact Blood and Fluid Warming System | The Surgical Company International B.V. | 2023 | — |
| 0 (this device) | K252636 | Fluido Compact System | The Surgical Company International B.V. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 1 | 1 |
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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K211618 | Fluido Compact Blood and Fluid Warming SystemSummary page 6…dicate Information Name of Predicate: Fluido® Compact Blood and Fluid Warming System 510(k) Number: K211618 This predicate has not been subject to a design-related recall.… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K060537Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow AC Power Supply, Model 120Enginivity, LLC · 2006 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K973741Bair Hugger Blood/Fluid WarmerAugustine Medical, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 48 years and passes through 5 companies; a new generation was cleared every 5.8 years on median.
- 5 of the 8 ancestors have a recall of any class; 2 have a Class I 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. 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?
The device can be used with the following products:
• Plasma
• Packed red blood cells
• Crystalloid intra venous (IV) fluids
• Synthetic Colloid intra venous (IV) fluids
The system is indicated to be used in a healthcare environment to help prevent hypothermia. The devices can be used in the full clinical environment. The Fluido Compact System can be used in adult and pediatric patients (weighing 3.5 kg or more) who require fluid warming prior to the administration of blood products or IV fluids to help prevent hypothermia. The system is intended to be used by healthcare professionals, e.g., nurses, medical specialists, and doctors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252636 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252636: Fluido Compact System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252636
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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