510(k) · Cleared
ClearedEthmoid Sinus Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acclarent, Inc. · KAM Cannula, Sinus
Cleared on Sep 15, 2006 after a 23-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Sep 15, 2006
- Review
- 23 days
- Class
- Class I
- Product code
- KAM
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK062458 Ethmoid Sinus SpacerAcclarent, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK072891 Sinus SpacerAcclarent, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK083574 Relieva Stratus Microflow SpacerAcclarent, Inc. · 2009
- Descendant · 3 generations on · 1 of its ownK093594 Modification to Relieva Stratus Microflow SpacerAcclarent, Inc. · 2010
- Descendant · 4 generations on · 0 of its ownK110687 Relieva Stratus Pro Microflow Spacer (Frontal)Acclarent, Inc. · 2011
Most influential descendants
Showing 4 of 4 · See all- K072891Sinus SpacerAcclarent, Inc. · 2008 · cites it directly3descendants
- K083574Relieva Stratus Microflow SpacerAcclarent, Inc. · 2009 · 2 generations on2descendants
- K093594Modification to Relieva Stratus Microflow SpacerAcclarent, Inc. · 2010 · 3 generations on1descendant
- K110687Relieva Stratus Pro Microflow Spacer (Frontal)Acclarent, Inc. · 2011 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062458 | Ethmoid Sinus Spacer | Acclarent, Inc. | 2006 | — |
| +1 | K072891 | Sinus Spacer | Acclarent, Inc. | 2008 | — |
| +2 | K083574 | Relieva Stratus Microflow Spacer | Acclarent, Inc. | 2009 | — |
| +3 | K093594 | Modification to Relieva Stratus Microflow Spacer | Acclarent, Inc. | 2010 | — |
| +4 | K110687 | Relieva Stratus Pro Microflow Spacer (Frontal) | Acclarent, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 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?
The FDA summary names no predicate by number.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072891 | Sinus Spacer | 2008 | 3 |
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?
- Of its descendants, K072891 (Acclarent, Inc., 2008) has gone furthest, with 3 descendants of its own.
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 Ethmoid Sinus Spacer is indicated for use as a postoperative spacer to maintain an opening to the ethmoid sinus within the first 14 days following surgery. The Ethmoid Sinus Spacer also helps to prevent obstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062458 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062458: Ethmoid Sinus Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062458
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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