510(k) · Cleared
ClearedMinnesota Medical Technologies Fecal Incontinence Insert (My Miracle)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minnesota Medical Technologies · PBP Rectal Insert
Cleared on Jul 22, 2025 as substantially equivalent to K122003 (Renew Medical, Inc., 2012) after a 265-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Jul 22, 2025
- Review
- 265 days
- Class
- Class II
- Product code
- PBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K864218 (1987). No later device cites it as a predicate yet.
- Root · 3 generations backK864218 ProconHealthcare Management Systems · 1987
- 2 generations backK042431 PROCON2Incontinent Control Devices, Inc. · 2005
- 1 generation backK122003 Renew InsertRenew Medical, Inc. · 2012
- This deviceK243367 Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)Minnesota Medical Technologies · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864218 | Procon | Healthcare Management Systems | 1987 | — |
| −2 | K042431 | PROCON2 | Incontinent Control Devices, Inc. | 2005 | — |
| −1 | K122003 | Renew Insert | Renew Medical, Inc. | 2012 | — |
| 0 (this device) | K243367 | Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) | Minnesota Medical Technologies | 2025 | — |
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 PBP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K122003 | Renew InsertSummary page 5…name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PBP III. PREDICATE DEVICE Renew Medical Inc., Renew Insert, K122003 Reference device: Eclipse System DEN140020 IV. DEVICE DESCRIPTION The device is a simple rectal insert which is… | 2012 |
| † | DEN140020 | Eclipse System | 2015 |
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 38 years and passes through 4 companies; a new generation was cleared every 12.7 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All PBP devicesPBP Rectal Insert: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PBP
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PBP
Too few PBP 510(k)s in any year since 2007 to give a median.
Recalls per year · PBP
No recall names PBP since 2007.
Adverse event reports per year · PBP
No MAUDE report names PBP 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 | 1 | — | 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 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The fecal incontinence insert is indicated for the management of accidental bowel leakage (ABL)
due to bowel incontinence. The rectal insert is designed for self-insertion to seal and help prevent
the involuntary leakage of stool from the rectum.
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/K243367 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243367: Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243367
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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