510(k) · Cleared
ClearedModification to Relieva Stratus Microflow 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 Mar 3, 2010 as substantially equivalent to K083574 (Acclarent, Inc., 2009) after a 104-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it.
- Decided
- Mar 3, 2010
- Review
- 104 days
- Class
- Class I
- Product code
- KAM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K912418 (1991). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK912418 Shikani Middle Meatal Antrostomy Vent TubeMicromedics, Inc. · 1991
- 2 generations backK072891 Sinus SpacerAcclarent, Inc. · 2008
- 1 generation backK083574 Relieva Stratus Microflow SpacerAcclarent, Inc. · 2009
- This deviceK093594 Modification to Relieva Stratus Microflow SpacerAcclarent, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK110687 Relieva Stratus Pro Microflow Spacer (Frontal)Acclarent, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K110687Relieva Stratus Pro Microflow Spacer (Frontal)Acclarent, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912418 | Shikani Middle Meatal Antrostomy Vent Tube | Micromedics, Inc. | 1991 | — |
| −2 | K072891 | Sinus Spacer | Acclarent, Inc. | 2008 | — |
| −1 | K083574 | Relieva Stratus Microflow Spacer | Acclarent, Inc. | 2009 | — |
| 0 (this device) | K093594 | Modification to Relieva Stratus Microflow Spacer | Acclarent, Inc. | 2010 | — |
| +1 | K110687 | Relieva Stratus Pro Microflow Spacer (Frontal) | Acclarent, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K083574 | Relieva Stratus Microflow SpacerSummary page 1…4800 Classification Name: Manual surgical instrument for general use Product Code: KAM Predicate Device: Refieva Stratus MicroFlow Spacer (K083574) Device Description: The MicroFlow Spacer is a device that maintains an opening at the target… | 2009 |
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 |
|---|---|---|---|
| K110687 | Relieva Stratus Pro Microflow Spacer (Frontal) | 2011 | 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 19 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K110687 (Acclarent, Inc., 2011) has gone furthest, with 0 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. 2010, this device’s year, is highlighted.
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 MicroFlow Spacer (Frontal) is indicated for use as a postoperative spacer to maintain an opening to the frontal sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction.
The MicroFlow Spacer (Ethmoid) is indicated for use as a postoperative spacer to maintain an opening to the ethmoid sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093594 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093594: Modification to Relieva Stratus Microflow Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093594
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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