510(k) · Cleared
ClearedXenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Optical Co., Ltd. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Dec 26, 2001 as substantially equivalent to K921707 (Pentax Precision Instrument Corp., 1992) and 2 other predicates after a 57-day review. Its family tree reaches back 3 generations to 1993. 5 of the 185 devices in its family, counting itself, have a Class I recall. 176 later devices descend from it.
- Decided
- Dec 26, 2001
- Review
- 57 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K931154 (1993). 8 ancestors in all, the oldest K850978 (1985). 176 later devices descend from it, 7 citing it directly. 5 of the 185 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 2 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 1 generation backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- This deviceK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- Descendant · cites it directly · 160 of its ownK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- Descendant · cites it directly · 159 of its ownK052452 Visera Rhino-Laryngovideoscope Olympus Enf Type VTOlympus Medical Systems Corporation · 2005
- Descendant · 2 generations on · 159 of its ownK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- Descendant · 2 generations on · 158 of its ownK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- Descendant · 3 generations on · 132 of its ownK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
Showing 5 of 176 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 176 · See all- K021073Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002 · cites it directly160descendants
- K052452Visera Rhino-Laryngovideoscope Olympus Enf Type VTOlympus Medical Systems Corporation · 2005 · cites it directly159descendants
- K031648Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003 · 2 generations on159descendants
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 2 generations on158descendants
- K100584Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · 3 generations on132descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −2 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −1 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| 0 (this device) | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| +1 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| +1 | K052452 | Visera Rhino-Laryngovideoscope Olympus Enf Type VT | Olympus Medical Systems Corporation | 2005 | — |
| +2 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| +2 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| +3 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 1 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 1 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 11 | 0 |
| 2019 | 13 | 1 |
| 2020 | 19 | 0 |
| 2021 | 11 | 1 |
| 2022 | 13 | 0 |
| 2023 | 17 | 0 |
| 2024 | 17 | 0 |
| 2025 | 21 | 1 |
| 2026 | 17 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K921707 | Pentax Naso-Pharyngo-Laryngoscope FNL-15P2/15RP2Summary page 2…CFR 876.1500 21CFR 868.5530 21CFR 874.4760 C. Predicate Devices: Device Description & Model Manufacturer 510(k)#/ Date Cleared Pentax Naso-Pharyngo- #K921707 Pentax Precision Laryngosocope 07/01/1992 Instrument Corp FNL-15P2/15RP2 Laparoscope, #K950103 Olympus America,Inc. Hand Inst… | 1992 |
| * | K950103 | Laparoscope, Hand InstrumentsSummary page 2…on & Model Manufacturer 510(k)#/ Date Cleared Pentax Naso-Pharyngo- #K921707 Pentax Precision Laryngosocope 07/01/1992 Instrument Corp FNL-15P2/15RP2 Laparoscope, #K950103 Olympus America,Inc. Hand Instruments 03/06/1995 LF-TP/DP #K981543 Olympus Optical Co., 08/06/1998 D. Summary Description of t… | 1995 |
| * | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary…Summary page 2…- #K921707 Pentax Precision Laryngosocope 07/01/1992 Instrument Corp FNL-15P2/15RP2 Laparoscope, #K950103 Olympus America,Inc. Hand Instruments 03/06/1995 LF-TP/DP #K981543 Olympus Optical Co., 08/06/1998 D. Summary Description of the Device 1. Summary This subject device "XENF-TP Rhino-Laryngofiber… | 1998 |
What descends from it? (176)
See all 1767 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | 2002 | 160 |
| K052452 | Visera Rhino-Laryngovideoscope Olympus Enf Type VT | 2005 | 159 |
| K070752 | Ksea Miniature Endoscope, Model 11565 | 2007 | 6 |
| K190972 | Ambu aScope 4 RhinoLaryngo Intervention | 2019 | 2 |
| K181240 | Rhino-Laryngo Fiberscope Olympus ENF-GP2 | 2018 | 1 |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D | 2026 | 0 |
| K200342 | Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use… | 2020 | 0 |
Has anything in its family been recalled? (5 Class I)
No FDA recall names this device.
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 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 16 Class I recalls
- K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 18 Class I recalls
- K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp. · 2019 · 5 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 · 5 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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K021073 (Olympus America, Inc., 2002) has gone furthest, with 160 descendants of its own.
- 3 other devices also cite its predicate K921707.
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 | — |
What is it indicated for?
This instrument has been designed to be used with an Olympus Light Source or an Olympus Miniature Light Source, documentation equipment, display monitor, Endo-Therapy Accessories and other ancillary equipment for endoscopic diagnosis and treatment within the nasal and nasopharyngeal lumen. MAJ-524 is a detachable battery powered Miniature Light Source, which has been designed to be used with the XENF-TP. These instruments have been designed to be used…
Read the full statement (174 words)
This instrument has been designed to be used with an Olympus Light Source or an Olympus Miniature Light Source, documentation equipment, display monitor, Endo-Therapy Accessories and other ancillary equipment for endoscopic diagnosis and treatment within the nasal and nasopharyngeal lumen.
MAJ-524 is a detachable battery powered Miniature Light Source, which has been designed to be used with the XENF-TP.
These instruments have been designed to be used with an Olympus endoscope to collect tissue within the nasal and nasopharyngeal lumen.
These instruments has been designed to be used with an Olympus endoscope to retrieve foreign bodies, calculi or resected tissue from the nasal and nasopharyngeal lumen.
These instruments has been designed to be used with an Olympus endoscope to collect tissue specimens within the nasal and nasopharyngeal lumen.
These instruments has been designed to be used with an Olympus endoscope to perform endoscopic vascular or submucosal injection within the nasal and nasopharyngeal lumen.
These instruments has been designed to be used with an Olympus endoscope for spraying medications in the nasal and nasopharyngeal lumen.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013591 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013591: Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013591
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026