510(k) · Cleared
ClearedMediplus Single Use GI Manometry Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mediplus, Ltd. · KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
Cleared on Aug 5, 2002 after a 270-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Aug 5, 2002
- Review
- 270 days
- Class
- Class II
- Product code
- KLA
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK013704 Mediplus Single Use GI Manometry CatheterMediplus, Ltd. · 2002
- Descendant · cites it directly · 1 of its ownK032138 Medtronic Single Use Esophageal Manometric Catheter, Medtronic…Medtronic Vascular · 2003
- Descendant · cites it directly · 0 of its ownK062362 Single Use Esophageal Manometey Catheters and Single Use Ano-Rectal…Sarmed Srl · 2007
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 |
|---|---|---|---|---|---|
| 0 (this device) | K013704 | Mediplus Single Use GI Manometry Catheter | Mediplus, Ltd. | 2002 | — |
| +1 | K032138 | Medtronic Single Use Esophageal Manometric Catheter, Medtronic Single Use… | Medtronic Vascular | 2003 | — |
| +1 | K062362 | Single Use Esophageal Manometey Catheters and Single Use Ano-Rectal Manometry… | Sarmed Srl | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 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 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
- #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 |
|---|---|---|---|
| * | — | Arndorfer Esophageal Manometry Catheter Named without a submission number | |
| * | — | Dentsleeve Manometric Multilumen Extrusion Named without a submission number |
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? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K032138 (Medtronic Vascular, 2003) has gone furthest, with 1 descendant of its own.
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.
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?
The Mediplus Single Use GI Manometry Catheter is intended for water-perfused manometry of the GI tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013704 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013704: Mediplus Single Use GI Manometry Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013704
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026