510(k) · Cleared
Recalled · Class II · 2014Thermedx Prodigy Fluid Management System, Models P1000, P2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermedx, LLC · HIG Insufflator, Hysteroscopic
Cleared on Jul 23, 2010 as substantially equivalent to K060939 (Arizant Healthcare, Inc., 2006) and 2 other predicates after a 388-day review. Its family tree reaches back 3 generations to 1987. 2 of the 12 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 23, 2010
- Review
- 388 days
- Class
- Class II
- Product code
- HIG
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 3 generations to K873435 (1987). 7 ancestors in all. 4 later devices descend from it, 1 citing it directly. 2 of the 12 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 deviceK091939 Thermedx Prodigy Fluid Management System, Models P1000, P2000Thermedx, LLC · 2010
- Descendant · cites it directly · 3 of its ownK133799 Thermedx Fluid Managment SystemThermedx, LLC · 2014 · Recalled
- Descendant · 2 generations on · 2 of its ownK172048 FluidSmartThermedx, LLC · 2017 · Recalled
- Descendant · 3 generations on · 0 of its ownK251273 Asurys Fluid Management SystemBoston Scientific Corporation · 2026
- Descendant · 3 generations on · 0 of its ownK210628 X-FLO Fluid Management SystemThermedx, LLC · 2021
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K133799Thermedx Fluid Managment SystemThermedx, LLC · 2014 · cites it directly3descendants
- K172048FluidSmartThermedx, LLC · 2017 · 2 generations on2descendants
- K251273Asurys Fluid Management SystemBoston Scientific Corporation · 2026 · 3 generations on0descendants
- K210628X-FLO Fluid Management SystemThermedx, LLC · 2021 · 3 generations on0descendants
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) | K091939 | Thermedx Prodigy Fluid Management System, Models P1000, P2000 | Thermedx, LLC | 2010 | — |
| +1 | K133799 | Thermedx Fluid Managment System | Thermedx, LLC | 2014 | 2 |
| +2 | K172048 | FluidSmart | Thermedx, LLC | 2017 | 1 |
| +3 | K251273 | Asurys Fluid Management System | Boston Scientific Corporation | 2026 | — |
| +3 | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K050058 | FDA’s K050058 is Theken Reveal VBR System The summary prints BK050058, a CBER number, which our reading took as K050058, FDA’s number for Theken Reveal VBR System (Theken Surgical,Llc). Its FDA name has none of the distinctive words the summary uses for the device it names, “Fluido®&Blood and Fluid Warmer”. Kept off the family tree. Summary page 1…Thermedx 37-5 is substantially equivalent in terms of safety and effectiveness to the following combination of predicate devices: 1. Fluido®&Blood and Fluid Warmer (BK050058) and Fluido Accessories (BK 0700755), The Surgical Company International 2. Ranger® Irrigation Fluid Warming System (K0609… | 2005 |
| Kept off the family tree | K070755 | FDA’s K070755 is Interworks Our reading of the summary gave K070755, FDA’s number for Interworks (Avreo, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Fluido Accessories”. Kept off the family tree. | 2007 |
| * | K060939 | Ranger Irrigation Fluid Warming SystemSummary page 1…1. Fluido®&Blood and Fluid Warmer (BK050058) and Fluido Accessories (BK 0700755), The Surgical Company International 2. Ranger® Irrigation Fluid Warming System (K060939), Arizant Healthcare Inc. 3. Level I1®DNORMOFLO ® Irrigation Fluid Warmer (K072080), Smiths Medical ASD, Inc. 4. Dolphin® II1… | 2006 |
| * | K072080 | Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming…Summary page 1…he Surgical Company International 2. Ranger® Irrigation Fluid Warming System (K060939), Arizant Healthcare Inc. 3. Level I1®DNORMOFLO ® Irrigation Fluid Warmer (K072080), Smiths Medical ASD, Inc. 4. Dolphin® II1Fluid Management System (KOI1 1876), Gyrus AGMI, Inc. S. HydroFlex® Irrigation Syst… | 2008 |
| * | K011876 | Dolphin II Fluid Management System, Model Dol-2 | 2002 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133799 | Thermedx Fluid Managment System | 2014 | 3 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 1, 2014 | Class II | Z-1463-2015 | Software design | To correct software bugs that could affect the ability to accurately measure fluid deficit. |
| Feb 10, 2014 | Class II | Z-2555-2014 | Component design/selection | A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. The deficit display may be higher than the actual deficit when the fluid collection canister is fully loaded. |
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 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 7 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K133799 (Thermedx, LLC, 2014) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K060939.
How does its category compare?
All HIG devicesHIG Insufflator, Hysteroscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The 37-5 is a multi-purpose fluid management system indicated for the following:
* Laparoscopy: warming fluids for irrigation and aspiration
* Hysteroscopy: uterine distention during diagnostic and operative procedures
* Cystoscopy: distention of the bladder during diagnostic and operative procedures (with optional fluid warming)
* Arthroscopy: distention and irrigation of the knee, shoulder, and small joints, during diagnostic and operative procedures
During hysteroscopic, cystoscopic and arthroscopic procedures, the 37-5 can be used to monitor fluid deficit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091939 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091939: Thermedx Prodigy Fluid Management System, Models P1000, P2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091939
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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