510(k) · Cleared
ClearedMedtronic Single Use Esophageal Manometric Catheter, Medtronic Single Use Anorectal Manometric Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
Cleared on Oct 9, 2003 as substantially equivalent to K884527 (Zinetics Medical, Inc., 1989) and 3 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.
- Decided
- Oct 9, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- KLA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K884527 (1989). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK884527 Zinetics (R) EmcZinetics Medical, Inc. · 1989
- This deviceK032138 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 1 of 1 · See all- K062362Single Use Esophageal Manometey Catheters and Single Use Ano-Rectal Manometry CathetersSarmed Srl · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884527 | Zinetics (R) Emc | Zinetics Medical, Inc. | 1989 | — |
| 0 (this device) | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K884527 | Zinetics (R) EmcSummary page 1…Monitor, Esophageal Motility, and Tube 21 CFR 876.1725 Name of Predicate Device Zinetics EMC Esophageal Manometric Catheter (K884527) Zinetics Anorectal Manometric Catheter (K92 1682) Mediplus Eso… | 1989 |
| * | K921682 | Zinetics AmcSummary page 1…876.1725 Name of Predicate Device Zinetics EMC Esophageal Manometric Catheter (K884527) Zinetics Anorectal Manometric Catheter (K92 1682) Mediplus Esophageal Manometry Catheter (KO 13704) Latitude Eso… | 1994 |
| * | K013704 | Mediplus Single Use GI Manometry CatheterSummary page 2…ter (K884527, February 28, 1989) 0 Zinetics Anorectal Manometry Catheter (K921682, December 29, 1994) 0 Mediplus Esophageal Manometry Catheter (K013704, August 5,2002) 0 Latitude Esophageal Pressure Catheter and Latitude Ano-Rectal Pressure Catheter (K0… | 2002 |
| * | K022023 | Compass Esophageal Pressure Catheter, Model Gie-8500, Compass Ano-Rectal Pressure…Summary page 1…y Catheter (KO 13704) Latitude Esophageal Pressure Catheter and Latitude Ano- Rectal Pressure Catheter (K022023) Device Description The Medtronic Single Use Esophageal Manometric Catheter is intended for water-perfhsed manometry of the GI… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062362 | Single Use Esophageal Manometey Catheters and Single Use Ano-Rectal Manometry Catheters | 2007 | 0 |
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?
- None of the 4 ancestors has a recall.
- Of its descendants, K062362 (Sarmed Srl, 2007) has gone furthest, with 0 descendants 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 Medtronic Single Use Esophageal Manometric Catheter is intended for water-perfused manometry of the GI tract
The Medtronic Single Use Anorectal Manometric Catheter is intended for water-perfused manometry of the rectal and anal canal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032138: Medtronic Single Use Esophageal Manometric Catheter, Medtronic Single Use Anorectal Manometric Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032138
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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