510(k) · Cleared
Recalled · Class II · 2026FluidSmart
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermedx, LLC · HIG Insufflator, Hysteroscopic
Cleared on Sep 5, 2017 as substantially equivalent to K133799 (Thermedx, LLC, 2014) and 1 other predicate after a 61-day review. Its family tree reaches back 5 generations to 1987. 2 of the 12 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 5, 2017
- Review
- 61 days
- Class
- Class II
- Product code
- HIG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K873435 (1987). 9 ancestors in all. 2 later devices descend from it, 2 citing it directly. 2 of the 12 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK873435 Level 1 IR-600 Normothermic Irrigating SetLevel 1 Technologies, Inc. · 1987
- 4 generations backK060939 Ranger Irrigation Fluid Warming SystemArizant Healthcare, Inc. · 2006 · Recalled
- 3 generations backK072080 Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo…Smiths Medical Asd, Inc. · 2008 · Recalled (Class I)
- 2 generations backK091939 Thermedx Prodigy Fluid Management System, Models P1000, P2000Thermedx, LLC · 2010 · Recalled
- 1 generation backK133799 Thermedx Fluid Managment SystemThermedx, LLC · 2014 · Recalled
- This deviceK172048 FluidSmartThermedx, LLC · 2017
- Descendant · cites it directly · 0 of its ownK251273 Asurys Fluid Management SystemBoston Scientific Corporation · 2026
- Descendant · cites it directly · 0 of its ownK210628 X-FLO Fluid Management SystemThermedx, LLC · 2021
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K873435 | Level 1 IR-600 Normothermic Irrigating Set | Level 1 Technologies, Inc. | 1987 | — |
| −4 | K060939 | Ranger Irrigation Fluid Warming System | Arizant Healthcare, Inc. | 2006 | 1 |
| −3 | 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 |
| −1 | K133799 | Thermedx Fluid Managment System | Thermedx, LLC | 2014 | 2 |
| 0 (this device) | K172048 | FluidSmart | Thermedx, LLC | 2017 | — |
| +1 | K251273 | Asurys Fluid Management System | Boston Scientific Corporation | 2026 | — |
| +1 | K210628 | X-FLO Fluid Management System | Thermedx, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1998 | 1 | 1 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2026 | 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.
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 HIG device
- #1 K261706 Endomat Select (UP220)score 14.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K133799 | Thermedx Fluid Managment SystemSummary page 5…valent in terms of safety and effectiveness to the following predicate (legally marketed) devices: 1. Primary: Thermedx Fluid Management System (K133799) 2. Secondary: Smiths Medical’s NormoFlo® Irrigation Warmer Model H-1129 (K072080) IV. REFERENCE DEVIC… | 2014 |
| * | K072080 | Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming…Summary page 5…evices: 1. Primary: Thermedx Fluid Management System (K133799) 2. Secondary: Smiths Medical’s NormoFlo® Irrigation Warmer Model H-1129 (K072080) IV. REFERENCE DEVICE Kosin Technologies’ Piggyback Irrigating System (K040094) used as a reference as to clin… | 2008 |
| † | K040094 | Piggyback Irrigating System | 2004 |
What descends from it? (2)
2 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 |
|---|---|---|---|---|
| Apr 9, 2026 | Class II | Z-2166-2026 | Process change control | Due to nonconforming products being inadvertently distributed. |
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 30 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 5 of the 9 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K251273 (Boston Scientific Corporation, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HIG devicesHIG Insufflator, Hysteroscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · HIG
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HIG
175in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIG
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIG
45in 2025
MAUDE reports naming product code HIG, 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 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 1 | — | 0 | 5 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 4 | 175 | 0 | 10 |
| 2019 | 0 | — | 0 | 66 |
| 2020 | 1 | — | 0 | 31 |
| 2021 | 1 | — | 0 | 130 |
| 2022 | 0 | — | 0 | 66 |
| 2023 | 0 | — | 0 | 33 |
| 2024 | 1 | — | 0 | 45 |
| 2025 | 0 | — | 0 | 45 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
Intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.
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/K172048 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172048: FluidSmart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172048
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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