510(k) · Cleared
ClearedMucosal Impedance Measurement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alandra Medical Sapi DE CV · QIS Esophageal, Mucosal, Electrical Characterization
Cleared on Sep 6, 2024 as substantially equivalent to DEN180067 (Diversatek Healthcare, Inc., 2019) and 1 other predicate after a 266-day review. Its family tree reaches back 3 generations to 1982.
- Decided
- Sep 6, 2024
- Review
- 266 days
- Class
- Class II
- Product code
- QIS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K820441 (1982). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK820441 Argyle PVC Feeding TubeSherwood Medical Co. · 1982
- 2 generations backK150084 Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU)…Covidien · 2015
- 1 generation backK213258 Nasogastric Feeding Tubes - ENFit Port - PVCCair Lgl · 2022
- This deviceK233974 Mucosal Impedance Measurement SystemAlandra Medical Sapi DE CV · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K820441 | Argyle PVC Feeding Tube | Sherwood Medical Co. | 1982 | — |
| −2 | K150084 | Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and… | Covidien | 2015 | — |
| −1 | K213258 | Nasogastric Feeding Tubes - ENFit Port - PVC | Cair Lgl | 2022 | — |
| 0 (this device) | K233974 | Mucosal Impedance Measurement System | Alandra Medical Sapi DE CV | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 2019 | 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 QIS? 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 QIS device
- #1 K230056 MiVu™ Esophageal Endo Capscore 5.2 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | DEN180067 | Mucosal Integrity Conductivity (MI) Test SystemSummary page 5…sophageal tissue characterization system Regulatory Class: Class II Product Code: QIS, PIF Predicate Devices Mucosal Integrity Conductivity (MI) Test System (DEN180067) Nasogastric Feeding Tubes – ENFit Port – PVC (K213258) Reference Devices Entarik Feeding Tube (K230206) Device… | 2019 |
| * | K213258 | Nasogastric Feeding Tubes - ENFit Port - PVCSummary page 5…II Product Code: QIS, PIF Predicate Devices Mucosal Integrity Conductivity (MI) Test System (DEN180067) Nasogastric Feeding Tubes – ENFit Port – PVC (K213258) Reference Devices Entarik Feeding Tube (K230206) Device Description The Mucosal Impedance Measurement System s… | 2022 |
| † | K230206 | Entarik Feeding Tube System; Entarik Feeding Tube | 2023 |
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 42 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate DEN180067.
How does its category compare?
All QIS devicesQIS Esophageal, Mucosal, Electrical Characterization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QIS
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QIS
Too few QIS 510(k)s in any year since 2007 to give a median.
Recalls per year · QIS
No recall names QIS since 2007.
Adverse event reports per year · QIS
No MAUDE report names QIS since 2007.
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 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Mucosal Impedance Measurement System is indicated for use by medical personnel trained in the usage of enteral feeding tubes for the treatment of adult patients requiring gastric decompression or enteral feeding for the delivery nutrition, fluids, and medications to the patient from an enteral feeding syringe or feedings set designed with ENFit connectors. The measurements of the Mucosal Impedance Measurement System are collected in patients…
Read the full statement (125 words)
The Mucosal Impedance Measurement System is indicated for use by medical personnel trained in the usage of enteral feeding tubes for the treatment of adult patients requiring gastric decompression or enteral feeding for the delivery nutrition, fluids, and medications to the patient from an enteral feeding syringe or feedings set designed with ENFit connectors. The measurements of the Mucosal Impedance Measurement System are collected in patients indicated for enteral feeding. This product is single use for no longer than 24 hours.
The Mucosal Impedance Measurement System is equipped with sensors designed to collect and display real time and continuous gastric reactance “XL” measurements. The device is not for use as a sole diagnostic screening tool and is restricted to prescription use in a hospital environment.
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/K233974 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233974: Mucosal Impedance Measurement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233974
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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