510(k) · Cleared
ClearedSoft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2 IV Warmer and the Thermal Sac Pressure Infuser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Smithworks Company · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Dec 22, 2006 as substantially equivalent to K973741 (Augustine Medical, Inc., 1998) and 5 other predicates after a 269-day review. Its family tree reaches back 2 generations to 1977. 1 of the 10 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Dec 22, 2006
- Review
- 269 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K770232 (1977). 8 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK770232 Blood/Fluid Warmer Model DW-1000AGorman Rupp Industries · 1977
- 1 generation backK984640 Thermal AngelEstill Medical Technologies, Inc. · 1999 · Recalled
- This deviceK060851 Soft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2…The Smithworks Company · 2006
- Descendant · cites it directly · 0 of its ownK120860 Infu Box Type 0412AMedical Rescue Equipment Holding AS · 2012
Class I recalls in this family
- K973741 Bair Hugger Blood/Fluid Warmerdirect predicate · 1998
Most influential descendants
Showing 1 of 1 · See all- K120860Infu Box Type 0412AMedical Rescue Equipment Holding AS · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K770232 | Blood/Fluid Warmer Model DW-1000A | Gorman Rupp Industries | 1977 | — |
| −1 | K984640 | Thermal Angel | Estill Medical Technologies, Inc. | 1999 | 1 |
| 0 (this device) | K060851 | Soft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2 IV Warmer… | The Smithworks Company | 2006 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (6)
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 |
|---|---|---|---|
| * | K973741 | Bair Hugger Blood/Fluid WarmerSummary page 10…been cleared under the 510(k) PreMarket Notification process. The predicate devices are as follows: Product | Regulation 510(k) No. Trade Name Manufacturer Code Number K973741 | Bair Hugger Augustine BSB 864.9205 Blood/Fluid Warmer Medical, Inc. K984640 | Thermal Angel 200 Estill Medical BSB 864.9205 Blo… | 1998 |
| * | K984640 | Thermal AngelSummary page 10…evices are as follows: Product | Regulation 510(k) No. Trade Name Manufacturer Code Number K973741 | Bair Hugger Augustine BSB 864.9205 Blood/Fluid Warmer Medical, Inc. K984640 | Thermal Angel 200 Estill Medical BSB 864.9205 Blood/Fluid Warmer Technologies, Inc. K002409 | MaxOne IV Automatic LGZ, Unclassi… | 1999 |
| * | K002409 | Maxone, Blood, Blood Products and IV Fluid WarmerSummary page 10…73741 | Bair Hugger Augustine BSB 864.9205 Blood/Fluid Warmer Medical, Inc. K984640 | Thermal Angel 200 Estill Medical BSB 864.9205 Blood/Fluid Warmer Technologies, Inc. K002409 | MaxOne IV Automatic LGZ, Unclassified Fluid/Blood Warmer Medical subsequent | and Technologies, Inc. | code BSB | 864.9205 K921… | 2001 |
| * | K921395 | Hot SackSummary page 10…lood/Fluid Warmer Technologies, Inc. K002409 | MaxOne IV Automatic LGZ, Unclassified Fluid/Blood Warmer Medical subsequent | and Technologies, Inc. | code BSB | 864.9205 K921395 | Hot Sack and Optional | C.F. Electronics LGZ Unclassified Insulated IV Sleeve K012276 | Listed as “Heat Stack | Medical Solutio… | 1992 |
| * | K012276 | TEMP 3Summary page 10…id/Blood Warmer Medical subsequent | and Technologies, Inc. | code BSB | 864.9205 K921395 | Hot Sack and Optional | C.F. Electronics LGZ Unclassified Insulated IV Sleeve K012276 | Listed as “Heat Stack | Medical Solutions, | LGZ Unclassified and Devices™: filed as Inc, K041839 | “Temp 3” and “8None” Simila… | 2001 |
| * | K041839 | 8NONESummary page 10…and Optional | C.F. Electronics LGZ Unclassified Insulated IV Sleeve K012276 | Listed as “Heat Stack | Medical Solutions, | LGZ Unclassified and Devices™: filed as Inc, K041839 | “Temp 3” and “8None” Similarities: The Smithworks iv fluid warmer product line is designed to provide external warming of iv b… | 2005 |
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 |
|---|---|---|---|
| K120860 | Infu Box Type 0412A | 2012 | 0 |
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 29 years and passes through 3 companies; a new generation was cleared every 22.4 years on median.
- 3 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K120860 (Medical Rescue Equipment Holding AS, 2012) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K973741.
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 Soft Sack iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments. The FloorMount iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to…
Read the full statement (242 words)
The Soft Sack iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments.
The FloorMount iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments.
The PAK2 iv fluid warmer is indicated for the warming or thermal maintenance of intravenous fluids prior to administration. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in hospital, clinical and field environments.
The Thermal Sack Pressure Infuser is a thermal maintenance device. It is intended for use as an accessory for use with iv fluid warmer devices to enhance the ability to deliver thermal normal iv fluids in the field, by insulating the bag and tubing. This device is intended for use with crystalloid fluids only, such as normal saline and ringers lactate. This device is intended to be used by healthcare professionals in clinical and field environments. This device has not been tested for pediatric use.
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/K060851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060851: Soft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2 IV Warmer and the Thermal Sac Pressure Infuser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060851
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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