510(k) · Cleared
ClearedInfu Box Type 0412A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Rescue Equipment Holding AS · LGZ Warmer, Thermal, Infusion Fluid
Cleared on May 8, 2012 as substantially equivalent to K060851 (The Smithworks Company, 2006) and 1 other predicate after a 47-day review. Its family tree reaches back 3 generations to 1977. 1 of the 10 devices in its family, counting itself, has a Class I recall.
- Decided
- May 8, 2012
- Review
- 47 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K770232 (1977). 9 ancestors in all. No later device cites it as a predicate yet. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK770232 Blood/Fluid Warmer Model DW-1000AGorman Rupp Industries · 1977
- 2 generations backK984640 Thermal AngelEstill Medical Technologies, Inc. · 1999 · Recalled
- 1 generation backK060851 Soft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2…The Smithworks Company · 2006
- This deviceK120860 Infu Box Type 0412AMedical Rescue Equipment Holding AS · 2012
Class I recalls in this family
- K973741 Bair Hugger Blood/Fluid Warmerdirect predicate · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K770232 | Blood/Fluid Warmer Model DW-1000A | Gorman Rupp Industries | 1977 | — |
| −2 | K984640 | Thermal Angel | Estill Medical Technologies, Inc. | 1999 | 1 |
| −1 | K060851 | Soft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2 IV Warmer… | The Smithworks Company | 2006 | — |
| 0 (this device) | K120860 | Infu Box Type 0412A | Medical Rescue Equipment Holding AS | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1998 | 1 | 1 |
| 2001 | 2 | 0 |
| 2005 | 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K060851 | Soft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2 IV Warmer and the…Summary page 1…: Warmer, Thermal, Infusion fluid 4. Product code: LGZ 5.5 Predicate Devices Soft Sack, FloorMount and Pak 2, IV warmer devices (K06085 1) and flair Hugger® Blood/Fuid Warmer (K973741) 5.6 Indications for Use The INFU Box is indicated for the regulation of temperat… | 2006 |
| * | K973741 | Bair Hugger Blood/Fluid WarmerSummary page 1…4. Product code: LGZ 5.5 Predicate Devices Soft Sack, FloorMount and Pak 2, IV warmer devices (K06085 1) and flair Hugger® Blood/Fuid Warmer (K973741) 5.6 Indications for Use The INFU Box is indicated for the regulation of temperature of intravenous (IV) fluid bags prior to ad… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K973741Bair Hugger Blood/Fluid WarmerAugustine Medical, Inc. · 1998 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- 3 of the 9 ancestors have a recall of any class; 1 has 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. 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 INFU Box is indicated for the regulation of temperature of intravenous (IV) fluids bags prior to administration. The device is intended for bags with crystalloid fluids only. Intended users are health care professionals. The device is intended for use in clinical and field environments and is intended to be mounted in a ground based field operating vehicle, such as ambulance or military vehicle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120860 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120860: Infu Box Type 0412A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120860
Report an extraction error
Are you the manufacturer?
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