510(k) · Cleared
Recalled · Class I · 2021Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming Set, Models, IR-40, IR-500, IR-600,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Jun 2, 2008 as substantially equivalent to K936223 (Level 1 Technologies, Inc., 1994) and 2 other predicates after a 308-day review. Its family tree reaches back 2 generations to 1987. 2 of the 13 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Jun 2, 2008
- Review
- 308 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- 2 (2 Class I)
- Predicates
- 3
Its longest line of descent runs back 2 generations to K873435 (1987). 5 ancestors in all. 7 later devices descend from it, 4 citing it directly. 2 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK873435 Level 1 IR-600 Normothermic Irrigating SetLevel 1 Technologies, Inc. · 1987
- 1 generation backK060939 Ranger Irrigation Fluid Warming SystemArizant Healthcare, Inc. · 2006 · Recalled
- This deviceK072080 Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo…Smiths Medical Asd, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK091939 Thermedx Prodigy Fluid Management System, Models P1000, P2000Thermedx, LLC · 2010 · Recalled
- Descendant · 2 generations on · 3 of its ownK133799 Thermedx Fluid Managment SystemThermedx, LLC · 2014 · Recalled
- Descendant · cites it directly · 2 of its ownK172048 FluidSmartThermedx, LLC · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK262532 NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601…ICU Medical · 2026
- Descendant · 2 generations on · 0 of its ownK251273 Asurys Fluid Management SystemBoston Scientific Corporation · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K973741 Bair Hugger Blood/Fluid Warmer2 generations back · 1998
Most influential descendants
Showing 5 of 7 · See all- K091939Thermedx Prodigy Fluid Management System, Models P1000, P2000Thermedx, LLC · 2010 · cites it directly4descendants
- K133799Thermedx Fluid Managment SystemThermedx, LLC · 2014 · 2 generations on3descendants
- K172048FluidSmartThermedx, LLC · 2017 · cites it directly2descendants
- K262532NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)ICU Medical · 2026 · cites it directly0descendants
- K251273Asurys Fluid Management SystemBoston Scientific Corporation · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K873435 | Level 1 IR-600 Normothermic Irrigating Set | Level 1 Technologies, Inc. | 1987 | — |
| −1 | K060939 | Ranger Irrigation Fluid Warming System | Arizant Healthcare, Inc. | 2006 | 1 |
| 0 (this device) | K072080 | Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation… | Smiths Medical Asd, Inc. | 2008 | — |
| +1 | K091939 | Thermedx Prodigy Fluid Management System, Models P1000, P2000 | Thermedx, LLC | 2010 | 2 |
| +2 | K133799 | Thermedx Fluid Managment System | Thermedx, LLC | 2014 | 2 |
| +1 | K172048 | FluidSmart | Thermedx, LLC | 2017 | 1 |
| +1 | K262532 | NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501… | ICU Medical | 2026 | — |
| +2 | K251273 | Asurys Fluid Management System | Boston Scientific Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1998 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 2 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K936223 | Pressure Irrigating SystemSummary page 4…mon Name: Irrigation Fluid Warmer and lirigation Warming Set Classification Name: Warmer, Thermal, Infusion Fluid (Unclassified, Product Code LGZ) Predicate Device(s): K936223 Smiths Medical ASD, Inc. (formerly Level 1 Inc.), Pressure Irrigating System. K873435 Smiths Medical ASD, Inc. (formerly Level 1… | 1994 |
| * | K873435 | Level 1 IR-600 Normothermic Irrigating SetSummary page 4…r, Thermal, Infusion Fluid (Unclassified, Product Code LGZ) Predicate Device(s): K936223 Smiths Medical ASD, Inc. (formerly Level 1 Inc.), Pressure Irrigating System. K873435 Smiths Medical ASD, Inc. (formerly Level 1 Inc.), Level 1 IR-600 Normothermic Imgating Set K060939 Arizant Healthcarc Inc. Range… | 1987 |
| * | K060939 | Ranger Irrigation Fluid Warming SystemSummary page 4…dical ASD, Inc. (formerly Level 1 Inc.), Pressure Irrigating System. K873435 Smiths Medical ASD, Inc. (formerly Level 1 Inc.), Level 1 IR-600 Normothermic Imgating Set K060939 Arizant Healthcarc Inc. Ranger Irrigation Fluid Warming System Device Description: The Level 1° NORMOFLO® Imrigation Fluid Warm… | 2006 |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 6, 2021 | Class I | Z-2377-2021 | Device Design | There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use. |
| Aug 6, 2021 | Class I | Z-2376-2021 | Device Design | There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use. |
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 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 18.7 years on median.
- 2 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K091939 (Thermedx, LLC, 2010) has gone furthest, with 4 descendants 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. 2008, 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 Level 1® NORMOFLO® Irrigation Warming Set (Disposable Set) is a disposable irrigating fluid administration set, designed for use by trained medical professionals, for warming irrigating fluids. The Disposable Set is intended for use with the Level 1® H-1100 series NORMOFLO® Irrigation Fluid Warmers only.
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/K072080 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072080: Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming Set, Models, IR-40, IR-500, IR-600,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072080
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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