510(k) · Cleared
ClearedNORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ICU Medical · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Sep 18, 2026 as substantially equivalent to K072080 (Smiths Medical Asd, Inc., 2008) after a 58-day review. Its family tree reaches back 3 generations to 1987. 2 of the 7 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 18, 2026
- Review
- 58 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K873435 (1987). 6 ancestors in all. No later device cites it as a predicate yet. 2 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK873435 Level 1 IR-600 Normothermic Irrigating SetLevel 1 Technologies, Inc. · 1987
- 2 generations backK060939 Ranger Irrigation Fluid Warming SystemArizant Healthcare, Inc. · 2006 · Recalled
- 1 generation backK072080 Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo…Smiths Medical Asd, Inc. · 2008 · Recalled (Class I)
- This deviceK262532 NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601…ICU Medical · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K873435 | Level 1 IR-600 Normothermic Irrigating Set | Level 1 Technologies, Inc. | 1987 | — |
| −2 | K060939 | Ranger Irrigation Fluid Warming System | Arizant Healthcare, Inc. | 2006 | 1 |
| −1 | K072080 | Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation… | Smiths Medical Asd, Inc. | 2008 | Class I |
| 0 (this device) | K262532 | NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501… | ICU Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 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 |
|---|---|---|---|
| * | K072080 | Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming…Summary page 5…LGZ Predicate Device (Legally marketed device to which equivalence is claimed) Trade or Proprietary Name NORMOFLO Irrigation Warming Sets (K072080) Common or Usual Name Warmer, Thermal, Infusion Fluid Classification… | 2008 |
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.
- K072080Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming Set, Models, IR-40…Smiths Medical Asd, Inc. · 2008 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K973741Bair Hugger Blood/Fluid WarmerAugustine Medical, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 39 years and passes through 4 companies; a new generation was cleared every 18.3 years on median.
- 3 of the 6 ancestors have a recall of any class; 2 have a Class I recall.
- 3 other devices also cite its predicate K072080.
How does its category compare?
All LGZ devicesLGZ Warmer, Thermal, Infusion Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 NORMOFLO™ Irrigation Fluid Warming Sets and Accessories are intended for the administration of warmed irrigating fluids. The NORMOFLO™ Irrigation Fluid Warming Sets and Accessories are intended for use with NORMOFLO™ Irrigation Fluid Warmers only.
The NORMOFLO™ Irrigation Fluid Warming Sets and Accessories are intended for use with adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262532: NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262532
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026