510(k) · Cleared
ClearedX-FLO Fluid Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermedx, LLC · HIG Insufflator, Hysteroscopic
Cleared on Nov 4, 2021 as substantially equivalent to K172048 (Thermedx, LLC, 2017) after a 247-day review. Its family tree reaches back 6 generations to 1987. 2 of the 11 devices in its family, counting itself, have a Class I recall.
- Decided
- Nov 4, 2021
- Review
- 247 days
- Class
- Class II
- Product code
- HIG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K873435 (1987). 10 ancestors in all. No later device cites it as a predicate yet. 2 of the 11 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK873435 Level 1 IR-600 Normothermic Irrigating SetLevel 1 Technologies, Inc. · 1987
- 5 generations backK060939 Ranger Irrigation Fluid Warming SystemArizant Healthcare, Inc. · 2006 · Recalled
- 4 generations backK072080 Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo…Smiths Medical Asd, Inc. · 2008 · Recalled (Class I)
- 3 generations backK091939 Thermedx Prodigy Fluid Management System, Models P1000, P2000Thermedx, LLC · 2010 · Recalled
- 2 generations backK133799 Thermedx Fluid Managment SystemThermedx, LLC · 2014 · Recalled
- 1 generation backK172048 FluidSmartThermedx, LLC · 2017 · Recalled
- This deviceK210628 X-FLO Fluid Management SystemThermedx, LLC · 2021
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K873435 | Level 1 IR-600 Normothermic Irrigating Set | Level 1 Technologies, Inc. | 1987 | — |
| −5 | K060939 | Ranger Irrigation Fluid Warming System | Arizant Healthcare, Inc. | 2006 | 1 |
| −4 | K072080 | Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation… | Smiths Medical Asd, Inc. | 2008 | Class I |
| −3 | 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 |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K172048 | FluidSmartSummary page 4…lator, Hysteroscopic) Secondary Product Codes: LGZ (Warmer, Thermal, Infusion Fluid), HRX (Arthroscope) III. PREDICATE DEVICE IDENTIFICATION Name of Device: FluidSmart, K172048 The predicate device has not been subject to a design-related recall. IV. DEVICE DESCRIPTION The X-FLO Fluid Management System… | 2017 |
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 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K973741Bair Hugger Blood/Fluid WarmerAugustine Medical, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 6 of the 10 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K172048.
How does its category compare?
All HIG devicesHIG Insufflator, Hysteroscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 X-FLO Fluid Management System is intended to: • Warm and pump fluid, via intravenous (IV) bags or fluid bottles, to provide fluid distention and flushing of the uterus for gynecology procedures. The device can also measure fluid deficit of the surgical procedure. • Warm and pump fluid, via IV bags or fluid bottles, to provide fluid distention and flushing of the bladder and kidneys, or general distention and flushing, for urological procedures. The…
Read the full statement (123 words)
The X-FLO Fluid Management System is intended to:
• Warm and pump fluid, via intravenous (IV) bags or fluid bottles, to provide fluid distention and flushing of the uterus for gynecology procedures. The device can also measure fluid deficit of the surgical procedure.
• Warm and pump fluid, via IV bags or fluid bottles, to provide fluid distention and flushing of the bladder and kidneys, or general distention and flushing, for urological procedures. The device can also measure fluid deficit of the surgical procedure.
• Warm and pump fluid, via IV bags or fluid bottles, to provide fluid distention and flushing of the shoulder, knee, or other small joints for orthopedic procedures. The device can also measure fluid deficit of the surgical procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210628 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210628: X-FLO Fluid Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210628
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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