510(k) · Cleared
ClearedRED
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuraxis, Inc. · KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
Cleared on Dec 6, 2024 as substantially equivalent to K180135 (Thd Spa, 2018) and 1 other predicate after a 123-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Dec 6, 2024
- Review
- 123 days
- Class
- Class II
- Product code
- KLA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K931574 (1993). 10 ancestors in all, the oldest K823701 (1983). No later device cites it as a predicate yet.
- Root · 6 generations backK931574 Advance Model Uds-AdvLaborie Medical Technologies, Ltd. · 1993
- 5 generations backK073552 Laborie Urodynamic System with Tetra AccessoryLaborie Medical Technologies, Corp. · 2008
- 4 generations backK082701 Uronirs, Model 2000Urodynamix Technologies, Ltd. · 2008
- 3 generations backK120088 Mcompass Anorectal Manometry SystemMedspira, LLC · 2012 · Recalled
- 2 generations backK161785 THD AnopressThd Spa · 2017
- 1 generation backK180135 THD Anopress with THD SensyProbeThd Spa · 2018
- This deviceK242304 REDNeuraxis, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931574 | Advance Model Uds-Adv | Laborie Medical Technologies, Ltd. | 1993 | — |
| −5 | K073552 | Laborie Urodynamic System with Tetra Accessory | Laborie Medical Technologies, Corp. | 2008 | — |
| −4 | K082701 | Uronirs, Model 2000 | Urodynamix Technologies, Ltd. | 2008 | — |
| −3 | K120088 | Mcompass Anorectal Manometry System | Medspira, LLC | 2012 | 1 |
| −2 | K161785 | THD Anopress | Thd Spa | 2017 | — |
| −1 | K180135 | THD Anopress with THD SensyProbe | Thd Spa | 2018 | — |
| 0 (this device) | K242304 | RED | Neuraxis, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 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 KLA? 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 KLA device
- #1 K242666 Fecobionics Anorectal Systemscore 10.3 · 6 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K180135 | THD Anopress with THD SensyProbeSummary page 5…CFR 876.1725 Panel: Gastroenterology/Urology Product Code: KLA, FFX Primary Predicate: K180135 THD SpA THD Anopress with THD SensyProbe K823701 Mui SR1B Single-Use… | 2018 |
| * | K823701 | Motility CathetersSummary page 5…Product Code: KLA, FFX Primary Predicate: K180135 THD SpA THD Anopress with THD SensyProbe K823701 Mui SR1B Single-Use Anorectal Balloon Expulsion Device Device Description: RED has been… | 1983 |
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 31 years and passes through 6 companies; a new generation was cleared every 5.0 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 2 other devices also cite its predicate K180135.
How does its category compare?
All KLA devicesKLA Monitor, Esophageal Motility, Anorectal Motility, And Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · KLA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KLA
Too few KLA 510(k)s in any year since 2007 to give a median.
Recalls per year · KLA
No recall names KLA since 2007.
Adverse event reports per year · KLA
1in 2024
MAUDE reports naming product code KLA, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
RED is used to evaluate the neuromuscular function of the patient’s ability to expel its contents from the rectum and as a qualitative test for rectal hypersensitivity. RED helps identify patients with rectal hypersensitivity who experience desire or urge-to-defecate at lower volumes of distension. RED is intended to be used in a clinical setting by trained health care providers in adult populations.
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/K242304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242304: RED.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242304
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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