510(k) · Cleared
ClearedVisera Rhino-Laryngovideoscope Olympus Enf Type V
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 Jul 24, 2003 as substantially equivalent to K021073 (Olympus America, Inc., 2002) and 1 other predicate after a 57-day review. Its family tree reaches back 5 generations to 1993. 6 of the 172 devices in its family, counting itself, have a Class I recall. 159 later devices descend from it.
- Decided
- Jul 24, 2003
- Review
- 57 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K931154 (1993). 12 ancestors in all, the oldest K850978 (1985). 159 later devices descend from it, 1 citing it directly. 6 of the 172 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 4 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 3 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 2 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 1 generation backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- This deviceK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- Descendant · cites it directly · 158 of its ownK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- Descendant · 2 generations on · 132 of its ownK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- Descendant · 3 generations on · 57 of its ownK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
- Descendant · 2 generations on · 34 of its ownK111425 Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190Olympus Medical Systems Corp. · 2012 · Recalled
- Descendant · 3 generations on · 19 of its ownK123365 Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp. · 2013
Showing 5 of 159 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 159 · See all- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · cites it directly158descendants
- K100584Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · 2 generations on132descendants
- K112680Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · 3 generations on57descendants
- K111425Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190Olympus Medical Systems Corp. · 2012 · 2 generations on34descendants
- K123365Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp. · 2013 · 3 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −4 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −3 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −2 | 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 | — |
| 0 (this device) | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| +1 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| +2 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| +3 | K112680 | Evis Exera Iii Video System | Olympus Medical Systems Corporation | 2012 | 6 |
| +2 | K111425 | Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190 | Olympus Medical Systems Corp. | 2012 | 1 |
| +3 | K123365 | Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190 | Olympus Medical Systems Corp. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 2003 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 1 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 1 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 10 | 0 |
| 2019 | 12 | 1 |
| 2020 | 17 | 0 |
| 2021 | 10 | 1 |
| 2022 | 10 | 0 |
| 2023 | 16 | 0 |
| 2024 | 17 | 0 |
| 2025 | 21 | 1 |
| 2026 | 16 | 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.
6 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? (2)
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.
What descends from it? (159)
See all 1591 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061313 | Evis Exera 180 System Class I | 2006 | 158 |
Has anything in its family been recalled? (6 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.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 16 Class I recalls
- K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 18 Class I recalls
- K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp. · 2019 · 4 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 · 4 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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K061313 (Olympus Medical Systems Corporation, 2006) has gone furthest, with 158 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 | — |
What is it indicated for?
This instrument has been designed to be used with an OLYMPUS video system center, light source, documentation equipment, display monitor, strobe light source specified by OLYMPUS, and ancillary equipment for endoscopic diagnosis within the nasal lumens and airway anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031648: Visera Rhino-Laryngovideoscope Olympus Enf Type V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031648
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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