510(k) · Cleared
Recalled · Class II · 2016Pentax Naso-Pharyngo-Laryngoscope FNL-15P2/15RP2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax Precision Instrument Corp. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Jul 1, 1992 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 of the 259 devices in its family, counting itself, have a Class I recall. 258 later devices descend from it. It has been recalled once.
- Decided
- Jul 1, 1992
- Review
- 82 days
- Class
- Class II
- Product code
- EOB
- Recalls
- 1
- Predicates
- 0
258 later devices descend from it, 4 citing it directly. 5 of the 259 devices in this family, counting this one, have a Class I recall.
- This deviceK921707 Pentax Naso-Pharyngo-Laryngoscope FNL-15P2/15RP2Pentax Precision Instrument Corp. · 1992
- Descendant · cites it directly · 176 of its ownK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- Descendant · 2 generations on · 160 of its ownK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- Descendant · 2 generations on · 159 of its ownK052452 Visera Rhino-Laryngovideoscope Olympus Enf Type VTOlympus Medical Systems Corporation · 2005
- Descendant · 3 generations on · 159 of its ownK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- Descendant · 3 generations on · 158 of its ownK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
Showing 5 of 258 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 258 · See all- K013591Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary EquipmentOlympus Optical Co., Ltd. · 2001 · cites it directly176descendants
- K021073Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002 · 2 generations on160descendants
- K052452Visera Rhino-Laryngovideoscope Olympus Enf Type VTOlympus Medical Systems Corporation · 2005 · 2 generations on159descendants
- K031648Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003 · 3 generations on159descendants
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 3 generations on158descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K921707 | Pentax Naso-Pharyngo-Laryngoscope FNL-15P2/15RP2 | Pentax Precision Instrument Corp. | 1992 | — |
| +1 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| +2 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| +2 | K052452 | Visera Rhino-Laryngovideoscope Olympus Enf Type VT | Olympus Medical Systems Corporation | 2005 | — |
| +3 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| +3 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 1 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 9 | 0 |
| 2013 | 6 | 1 |
| 2014 | 7 | 0 |
| 2015 | 10 | 0 |
| 2016 | 4 | 0 |
| 2017 | 6 | 0 |
| 2018 | 13 | 0 |
| 2019 | 19 | 1 |
| 2020 | 22 | 0 |
| 2021 | 18 | 1 |
| 2022 | 20 | 0 |
| 2023 | 25 | 0 |
| 2024 | 24 | 0 |
| 2025 | 28 | 1 |
| 2026 | 20 | 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.
5 devices in this family have a Class I recall. 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? (258)
See all 2584 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | 2001 | 176 |
| K011869 | Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment | 2001 | 82 |
| K992526 | Flexible Nasopharyngo-Laryngoscopes, Flexible Bronchoscope | 1999 | 3 |
| K964815 | AP-4000, Air Pulse Sensory Stimulator | 1997 | 1 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 6, 2016 | Class II | Z-2074-2016 | Device Design | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 3 generations on · ◆ in the 2006 descendants bar of FIG. 16 Class I recalls
- K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 18 Class I recalls
- K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp. · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
- K250862Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii Bronchovideoscope (Olympus BF-P190)…Olympus Medical Systems Corp. · 2025 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 14 Class I recalls
- K201758EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190Olympus Medical Systems Corp. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K013591 (Olympus Optical Co., Ltd., 2001) has gone furthest, with 176 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/K921707 · printed Nov 4, 2026
Cite this page
510(k) Report. “K921707: Pentax Naso-Pharyngo-Laryngoscope FNL-15P2/15RP2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K921707
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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