510(k) · Cleared
ClearedAirway Fiberscopes, Models LS-9, 0L-1, 0L-2 & PL-2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reichert-Jung, Inc. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Feb 10, 1987 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- Feb 10, 1987
- Review
- 63 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 1 citing it directly.
- This deviceK864821 Airway Fiberscopes, Models LS-9, 0L-1, 0L-2 & PL-2Reichert-Jung, Inc. · 1987
- Descendant · cites it directly · 15 of its ownK080622 Entity Nasoview Led Nasopharyngoscope, Model 006105Optim, Inc. · 2008
- Descendant · 2 generations on · 9 of its ownK091829 PLS Portable Light SourceOptim, Inc. · 2009
- 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 · 2 generations on · 4 of its ownK100577 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K080622Entity Nasoview Led Nasopharyngoscope, Model 006105Optim, Inc. · 2008 · cites it directly15descendants
- K091829PLS Portable Light SourceOptim, Inc. · 2009 · 2 generations on9descendants
- K130503Pathassist Led Light FiberEntellus Medical, Inc. · 2013 · 3 generations on6descendants
- K141916Pathassist Led Light FiberEntellus Medical, Inc. · 2014 · 4 generations on5descendants
- K100577Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K864821 | Airway Fiberscopes, Models LS-9, 0L-1, 0L-2 & PL-2 | Reichert-Jung, Inc. | 1987 | — |
| +1 | K080622 | Entity Nasoview Led Nasopharyngoscope, Model 006105 | Optim, Inc. | 2008 | — |
| +2 | K091829 | PLS Portable Light Source | Optim, Inc. | 2009 | — |
| +3 | K130503 | Pathassist Led Light Fiber | Entellus Medical, Inc. | 2013 | — |
| +4 | K141916 | Pathassist Led Light Fiber | Entellus Medical, Inc. | 2014 | — |
| +2 | K100577 | Acclarent Cyclops Multi-Angle Endoscope | 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 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EOB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EOB device
- #1 K253184 Video Rhinolaryngoscope System (Disposable…score 14.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080622 | Entity Nasoview Led Nasopharyngoscope, Model 006105 | 2008 | 15 |
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, K080622 (Optim, Inc., 2008) has gone furthest, with 15 descendants of its own.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EOB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOB
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EOB
1,338in 2025
MAUDE reports naming product code EOB, 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 | 4 | 37 | 0 | 1 |
| 2008 | 4 | 38 | 0 | 1 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 209 | 2 | 3 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 3 | 282 | 0 | 5 |
| 2015 | 3 | 115 | 0 | 13 |
| 2016 | 3 | 174 | 0 | 16 |
| 2017 | 6 | 216 | 0 | 18 |
| 2018 | 6 | 230 | 0 | 23 |
| 2019 | 8 | 149 | 0 | 51 |
| 2020 | 3 | 175 | 0 | 47 |
| 2021 | 2 | — | 0 | 345 |
| 2022 | 6 | 178 | 1 | 1,158 |
| 2023 | 3 | 107 | 1 | 1,352 |
| 2024 | 2 | — | 0 | 1,498 |
| 2025 | 3 | 192 | 0 | 1,338 |
| 2026 | 5 | 180 | 1 | — |
https://510kreport.com/device/K864821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K864821: Airway Fiberscopes, Models LS-9, 0L-1, 0L-2 & PL-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K864821
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026