510(k) · Cleared
ClearedRenew Insert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renew Medical, Inc. · PBP Rectal Insert
Cleared on Oct 26, 2012 as substantially equivalent to K042431 (Incontinent Control Devices, Inc., 2005) after a 109-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it.
- Decided
- Oct 26, 2012
- Review
- 109 days
- Class
- Class II
- Product code
- PBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K864218 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK864218 ProconHealthcare Management Systems · 1987
- 1 generation backK042431 PROCON2Incontinent Control Devices, Inc. · 2005
- This deviceK122003 Renew InsertRenew Medical, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK243367 Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)Minnesota Medical Technologies · 2025
Most influential descendants
Showing 1 of 1 · See all- K243367Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)Minnesota Medical Technologies · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864218 | Procon | Healthcare Management Systems | 1987 | — |
| −1 | K042431 | PROCON2 | Incontinent Control Devices, Inc. | 2005 | — |
| 0 (this device) | K122003 | Renew Insert | Renew Medical, Inc. | 2012 | — |
| +1 | K243367 | Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) | Minnesota Medical Technologies | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 PBP? 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 PBP device
- #1 K243367 Minnesota Medical Technologies Fecal…score 10.3 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K042431 | PROCON2Summary page 1…he Renew Insert ("Insert") has the same intended use and function as commercially available medical devices: a) Procon2; Incontinent Control Device Inc. (#K042431) Intended Use The Renew Insert is indicated for the management of accidental bowel leakage due to bowel incontinence. The Ren… | 2005 |
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 |
|---|---|---|---|
| K243367 | Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) | 2025 | 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?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 18.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K243367 (Minnesota Medical Technologies, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PBP devicesPBP Rectal Insert: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Renew Insert is indicated for the management of accidental bowel leakage due to bowel incontinence. The Renew Insert is designed for self-insertion to seal and help prevent the involuntary leakage of stool from the rectum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122003 · printed Nov 3, 2026
Cite this page
510(k) Report. “K122003: Renew Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K122003
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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