510(k) · Cleared
ClearedArctx Cool Catheter Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arctx Medical · PLA Esophageal Thermal Regulation And Gastric Suctioning Device
Cleared on Oct 30, 2025 as substantially equivalent to K170029 (International Biophysics Corporation, 2017) after a 241-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Oct 30, 2025
- Review
- 241 days
- Class
- Class II
- Product code
- PLA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K852698 (1985). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK852698 Bio Medicus Bio Pump Model BP-80Bio Medicus, Inc. · 1985
- 2 generations backK983272 Ibc Flopump, Model 6000International Biophysics Corp. · 1999
- 1 generation backK170029 FloPump 32mL, Sterile, FloPump 32mL, Non-SterileInternational Biophysics Corporation · 2017 · Recalled
- This deviceK250632 Arctx Cool Catheter SetArctx Medical · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K852698 | Bio Medicus Bio Pump Model BP-80 | Bio Medicus, Inc. | 1985 | — |
| −2 | K983272 | Ibc Flopump, Model 6000 | International Biophysics Corp. | 1999 | — |
| −1 | K170029 | FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile | International Biophysics Corporation | 2017 | 1 |
| 0 (this device) | K250632 | Arctx Cool Catheter Set | Arctx Medical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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.
Planning a device in PLA? 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 PLA device
- #1 K233357 EsoCool Thermal Regulation Catheterscore 8.2 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K170029 | FloPump 32mL, Sterile, FloPump 32mL, Non-SterileSummary page 5…e: Esophageal Thermal Regulation And Gastric Suctioning Device Regulation Number: 21 CFR 870.5910 Product Code: PLA Legally Marketed Predicate Devices Predicate Number: K170029 Predicate Trade Name: Esophageal Cooling Device Predicate Product Code: PLA Device Description Summary The ACC Set is comprised… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 40 years and passes through 4 companies; a new generation was cleared every 13.5 years on median.
- 2 of the 4 ancestors have a recall of any class.
How does its category compare?
All PLA devicesPLA Esophageal Thermal Regulation And Gastric Suctioning Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PLA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PLA
56in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PLA
No recall names PLA since 2007.
Adverse event reports per year · PLA
2in 2024
MAUDE reports naming product code PLA, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 3 |
| 2018 | 3 | 56 | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Arctx Cool Catheter Set is a thermal regulating device, intended to: connect to a Blanketrol III Hyper-Hypothermia System to control patient temperature, allow enteral administration of fluids, and provide gastric decompression and suctioning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250632 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250632: Arctx Cool Catheter Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250632
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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