510(k) · Cleared
ClearedSingle Use Esophageal Manometey Catheters and Single Use Ano-Rectal Manometry Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sarmed Srl · KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
Cleared on Apr 13, 2007 as substantially equivalent to K032138 (Medtronic Vascular, 2003) and 2 other predicates after a 242-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Apr 13, 2007
- Review
- 242 days
- Class
- Class II
- Product code
- KLA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K884527 (1989). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K884527 | Zinetics (R) Emc | Zinetics Medical, Inc. | 1989 | — |
| −1 | K032138 | Medtronic Single Use Esophageal Manometric Catheter, Medtronic Single Use… | Medtronic Vascular | 2003 | — |
| 0 (this device) | 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 |
| 2004 | 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? (3)
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 |
|---|---|---|---|
| * | K032138 | Medtronic Single Use Esophageal Manometric Catheter, Medtronic Single Use Anorectal…Summary page 1…Medtronic Single Use Esophageal Manometric Catheter And Medtronic Predicate Devices Single Use Ano-Rectal Manometric Catheter (K032138) Mediplus Single Use Ano-Rectal Manometry Catheter (K031617) Medi… | 2003 |
| * | K031617 | Mediplus Single Use Lower GI Manometry CatheterSummary page 1…nic Predicate Devices Single Use Ano-Rectal Manometric Catheter (K032138) Mediplus Single Use Ano-Rectal Manometry Catheter (K031617) Mediplus Esophageal Manometry Catheter (KO13704)… | 2004 |
| * | K013704 | Mediplus Single Use GI Manometry Catheter | 2002 |
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 18 years and passes through 3 companies; a new generation was cleared every 14.6 years on median.
- None of the 6 ancestors has a recall.
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. 2007, 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?
The SarMed Single Use Esophageal Manometry Catheters and Ano-Rectal Manometry Catheters are indicated for patients where Gastro-Intestinal and Ano-Rectal tracts pressure measurements are required, such as for detection of GI tract disorders. The products are to be used by a trained physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062362: Single Use Esophageal Manometey Catheters and Single Use Ano-Rectal Manometry Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062362
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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