510(k) · Cleared
ClearedFrontal Sinus Trephination Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xomed, Inc. · KAM Cannula, Sinus
Cleared on Feb 8, 2000 as substantially equivalent to K925176 (Boston Scientific Corp, 1993) after a 53-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Feb 8, 2000
- Review
- 53 days
- Class
- Class I
- Product code
- KAM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925176 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK925176 Vansonnenberg Chest Drainage Catheter All PurposeBoston Scientific Corp · 1993
- This deviceK994262 Frontal Sinus Trephination CannulaXomed, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925176 | Vansonnenberg Chest Drainage Catheter All Purpose | Boston Scientific Corp | 1993 | — |
| 0 (this device) | K994262 | Frontal Sinus Trephination Cannula | Xomed, Inc. | 2000 | — |
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 KAM? 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? (4)
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 |
|---|---|---|---|
| * | K925176 | Vansonnenberg Chest Drainage Catheter All PurposeSummary page 2…t- term access to body cavities. Predicates include common peritoneal catheters and chest drainage tubes including the Vansonnenberg Chest Drainage Tubes as described m K925176. The occlusion plug provided to close the cannula lumen between irrigation procedures is substantially equivalent in design and… | 1993 |
| * | — | Medtronic Xomed Frontal Sinus Mini-Trephine Set irrigation cannula Named without a submission number | |
| * | — | Common peritoneal catheters Named without a submission number | |
| * | — | Catheter Plug marketed by Bard Medical Named without a submission 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.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All KAM devicesKAM Cannula, Sinus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KAM
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · KAM
Too few KAM 510(k)s in any year since 2007 to give a median.
Recalls per year · KAM
No recall names KAM since 2007.
Adverse event reports per year · KAM
3in 2016
MAUDE reports naming product code KAM, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 1 | — | 0 | 12 |
| 2011 | 1 | — | 0 | 8 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 3 |
| 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 Frontal Sinus Trephination Cannula is indicated for patients with sinus disease that require frontal sinus irrigation or repeated frontal sinus irrigation for up to thirty days.
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/K994262 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994262: Frontal Sinus Trephination Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994262
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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