510(k) · Cleared
ClearedColoplast Ostomy Rod, Model 12814
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast Corp. · EZP Rod, Colostomy
Cleared on Oct 13, 2006 as substantially equivalent to K811240 (E. R. Squibb & Sons, Inc., 1981) after a 423-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- Oct 13, 2006
- Review
- 423 days
- Class
- Class II
- Product code
- EZP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K811240 (1981). No later device cites it as a predicate yet.
- Root · 1 generation backK811240 Sur-Fit Loop Ostomy O.R. SetE. R. Squibb & Sons, Inc. · 1981
- This deviceK052229 Coloplast Ostomy Rod, Model 12814Coloplast Corp. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811240 | Sur-Fit Loop Ostomy O.R. Set | E. R. Squibb & Sons, Inc. | 1981 | — |
| 0 (this device) | K052229 | Coloplast Ostomy Rod, Model 12814 | Coloplast Corp. | 2006 | — |
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 EZP? 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 |
|---|---|---|---|
| * | K811240 | Sur-Fit Loop Ostomy O.R. SetSummary page 2…Ostomy Rod Common Na eLoI Otm o Classificationname Rod, Colostomy 5. Legally marketed device to which substantialequivalence is claimed ConvaTec Sur-Fit System K811240 6. Descreption of the device The Coloplast Ostomy Rod is a 90mm white HDPE rod with a fixed T at one end and a separate T pie… | 1981 |
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?
- Its one ancestor has no recall.
How does its category compare?
All EZP devicesEZP Rod, Colostomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EZP
FDA has decided no EZP device since 2007.
Median 510(k) review, days · EZP
Too few EZP 510(k)s in any year since 2007 to give a median.
Recalls per year · EZP
No recall names EZP since 2007.
Adverse event reports per year · EZP
9in 2022
MAUDE reports naming product code EZP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Coloplast Ostomy Rod is for use in loop ostomy surgery. The ostomy rod is a device that is placed through a loop of the colon brought out through the abdominal wall to temporarily keep it from slipping back through the surgical opening during the loop (colostomy) ostomy surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052229 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052229: Coloplast Ostomy Rod, Model 12814.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052229
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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