510(k) · Cleared
ClearedFoam Ring Port Protector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inspired Ideas, Incorporated · OBK Port, Protector/Cushion
Cleared on Apr 9, 2007 after a 248-day review. The FDA summary names no predicate by number.
- Decided
- Apr 9, 2007
- Review
- 248 days
- Class
- Class II
- Product code
- OBK
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 OBK? 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?
The FDA summary names no predicate by number.
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.
How does its category compare?
All OBK devicesOBK Port, Protector/Cushion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · OBK
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · OBK
Too few OBK 510(k)s in any year since 2007 to give a median.
Recalls per year · OBK
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OBK
No MAUDE report names OBK since 2007.
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 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 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 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The foam ring, with the hole in the center, may be used in conjunction with ports (e.g., chemotherapy, vascular, etc.), up to 1 3/8" (3.5 cm) in diameter and raising less than 3/8" above the skin.
The device is intended to cushion the localized area surrounding the port.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062261: Foam Ring Port Protector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062261
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026