510(k) · Cleared
ClearedLevel 1 IR-600 Normothermic Irrigating Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Level 1 Technologies, Inc. · KOD Catheter, Urological
Cleared on Oct 5, 1987 after a 40-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 10 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Oct 5, 1987
- Review
- 40 days
- Class
- Class II
- Product code
- KOD
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- This deviceK873435 Level 1 IR-600 Normothermic Irrigating SetLevel 1 Technologies, Inc. · 1987
- Descendant · cites it directly · 8 of its ownK060939 Ranger Irrigation Fluid Warming SystemArizant Healthcare, Inc. · 2006 · Recalled
- Descendant · cites it directly · 7 of its ownK072080 Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo…Smiths Medical Asd, Inc. · 2008 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK091939 Thermedx Prodigy Fluid Management System, Models P1000, P2000Thermedx, LLC · 2010 · Recalled
- Descendant · 3 generations on · 3 of its ownK133799 Thermedx Fluid Managment SystemThermedx, LLC · 2014 · Recalled
- Descendant · 2 generations on · 2 of its ownK172048 FluidSmartThermedx, LLC · 2017 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K072080 Normoflo Irrigation Fluid Warmer, Models H-1100…cites it directly · 2008
Most influential descendants
Showing 5 of 9 · See all- K060939Ranger Irrigation Fluid Warming SystemArizant Healthcare, Inc. · 2006 · cites it directly8descendants
- K072080Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming…Smiths Medical Asd, Inc. · 2008 · cites it directly7descendants
- K091939Thermedx Prodigy Fluid Management System, Models P1000, P2000Thermedx, LLC · 2010 · 2 generations on4descendants
- K133799Thermedx Fluid Managment SystemThermedx, LLC · 2014 · 3 generations on3descendants
- K172048FluidSmartThermedx, LLC · 2017 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 |
| +1 | K072080 | Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation… | Smiths Medical Asd, Inc. | 2008 | Class I |
| +2 | K091939 | Thermedx Prodigy Fluid Management System, Models P1000, P2000 | Thermedx, LLC | 2010 | 2 |
| +3 | K133799 | Thermedx Fluid Managment System | Thermedx, LLC | 2014 | 2 |
| +2 | K172048 | FluidSmart | Thermedx, LLC | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 1 |
| 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), 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 KOD device
- #1 K251864 Rubber Utility Catheterscore 10.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K072080Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming Set, Models, IR-40…Smiths Medical Asd, Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K060939 (Arizant Healthcare, Inc., 2006) has gone furthest, with 8 descendants of its own.
How does its category compare?
All KOD devicesKOD Catheter, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KOD
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · KOD
251in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KOD
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KOD
1,389in 2025
MAUDE reports naming product code KOD, 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 | 0 | — | 0 | 180 |
| 2008 | 2 | — | 0 | 102 |
| 2009 | 1 | — | 15 | 183 |
| 2010 | 1 | — | 1 | 228 |
| 2011 | 2 | — | 47 | 209 |
| 2012 | 0 | — | 2 | 165 |
| 2013 | 0 | — | 0 | 393 |
| 2014 | 1 | — | 0 | 226 |
| 2015 | 0 | — | 0 | 418 |
| 2016 | 2 | — | 1 | 284 |
| 2017 | 1 | — | 0 | 1,873 |
| 2018 | 6 | 251 | 0 | 1,179 |
| 2019 | 1 | — | 1 | 1,167 |
| 2020 | 0 | — | 0 | 1,370 |
| 2021 | 1 | — | 0 | 1,388 |
| 2022 | 2 | — | 3 | 1,280 |
| 2023 | 0 | — | 1 (1) | 1,160 |
| 2024 | 0 | — | 0 | 1,259 |
| 2025 | 0 | — | 0 | 1,389 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K873435 · printed Nov 4, 2026
Cite this page
510(k) Report. “K873435: Level 1 IR-600 Normothermic Irrigating Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K873435
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026