510(k) · Cleared
ClearedTEMP 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Solutions, Inc. · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Aug 20, 2001 after a 32-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Aug 20, 2001
- Review
- 32 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK012276 TEMP 3Medical Solutions, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK060851 Soft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2…The Smithworks Company · 2006
- Descendant · 2 generations on · 0 of its ownK120860 Infu Box Type 0412AMedical Rescue Equipment Holding AS · 2012
- Descendant · cites it directly · 0 of its ownK091336 Ivnow Modular Fluid Warmer, 120V, Model Ivnow-1, Ivnow-2, Ivnow-3…Enthermics Medical Systems, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- K060851Soft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2 IV Warmer and the…The Smithworks Company · 2006 · cites it directly1descendant
- K120860Infu Box Type 0412AMedical Rescue Equipment Holding AS · 2012 · 2 generations on0descendants
- K091336Ivnow Modular Fluid Warmer, 120V, Model Ivnow-1, Ivnow-2, Ivnow-3, Ivnow-6, Ivnow…Enthermics Medical Systems, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012276 | TEMP 3 | Medical Solutions, Inc. | 2001 | — |
| +1 | K060851 | Soft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2 IV Warmer… | The Smithworks Company | 2006 | — |
| +2 | K120860 | Infu Box Type 0412A | Medical Rescue Equipment Holding AS | 2012 | — |
| +1 | K091336 | Ivnow Modular Fluid Warmer, 120V, Model Ivnow-1, Ivnow-2, Ivnow-3, Ivnow-6… | Enthermics Medical Systems, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K060851 (The Smithworks Company, 2006) has gone furthest, with 1 descendant 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.
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 MEDICAL SOLUTIONS, INC TEMP 3 WARMING CABINET 1S DESIGNED TO STORE, REPIDLY WARM AND MAINTAIN TEMPERATURE OF I.V. FLUID BAGS AND IRRIGATION SOLUTION BAGS PRIOR TO THEIR USE.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012276 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012276: TEMP 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012276
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026