510(k) · Cleared
ClearedRelieva Luma Sinus Illumination System, Model Sis-100A
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 28, 2007 after an 85-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 19 later devices descend from it.
- Decided
- Sep 28, 2007
- Review
- 85 days
- Class
- Class I
- Product code
- KAM
- Recalls
- None
- Predicates
- 1
19 later devices descend from it, 4 citing it directly.
- This deviceK071845 Relieva Luma Sinus Illumination System, Model Sis-100AAcclarent, Inc. · 2007
- Descendant · cites it directly · 8 of its ownK111763 Pathassist Light FiberEntellus Medical, Inc. · 2011
- Descendant · 2 generations on · 7 of its ownK120962 Pathassist Light FiberEntellus Medical, Inc. · 2012
- Descendant · 3 generations on · 6 of its ownK130503 Pathassist Led Light FiberEntellus Medical, Inc. · 2013
- Descendant · 4 generations on · 5 of its ownK141916 Pathassist Led Light FiberEntellus Medical, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK110158 Illuminating Sinus SeekerEntellus Medical, Inc. · 2011
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K111763Pathassist Light FiberEntellus Medical, Inc. · 2011 · cites it directly8descendants
- K120962Pathassist Light FiberEntellus Medical, Inc. · 2012 · 2 generations on7descendants
- K130503Pathassist Led Light FiberEntellus Medical, Inc. · 2013 · 3 generations on6descendants
- K141916Pathassist Led Light FiberEntellus Medical, Inc. · 2014 · 4 generations on5descendants
- K110158Illuminating Sinus SeekerEntellus Medical, Inc. · 2011 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071845 | Relieva Luma Sinus Illumination System, Model Sis-100A | Acclarent, Inc. | 2007 | — |
| +1 | K111763 | Pathassist Light Fiber | Entellus Medical, Inc. | 2011 | — |
| +2 | K120962 | Pathassist Light Fiber | Entellus Medical, Inc. | 2012 | — |
| +3 | K130503 | Pathassist Led Light Fiber | Entellus Medical, Inc. | 2013 | — |
| +4 | K141916 | Pathassist Led Light Fiber | Entellus Medical, Inc. | 2014 | — |
| +1 | K110158 | Illuminating Sinus Seeker | Entellus Medical, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K043445 | Relieva Sinus Guidewire Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…21 CFR 878.4800 Classification Name: Manual surgical instrument for general use Product Code: KAM Predicate Device: RelievaTM Sinus Guidewire (K043445) Device Description: The Relieva LumaTM Sinus Illumination System is a flexible device that transm… |
What descends from it? (19)
See all 194 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K111763 (Entellus Medical, Inc., 2011) has gone furthest, with 8 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. 2007, 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 Relieva LumaTM Sinus Illumination System is intended to provide a means to access the sinus space for diagnostic and therapeutic procedures in conjunction with other nasal and sinus products. It is also intended to illuminate within and transilluminate across nasal and sinus structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071845 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071845: Relieva Luma Sinus Illumination System, Model Sis-100A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071845
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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