510(k) · Cleared
ClearedFlexible Nasopharyngo-Laryngoscopes, Flexible Bronchoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Sep 24, 1999 as substantially equivalent to K980401 (Richard Wolf Medical Instruments Corp., 1998) and 2 other predicates after a 58-day review. Its family tree reaches back 2 generations to 1996. 3 later devices descend from it.
- Decided
- Sep 24, 1999
- Review
- 58 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K962172 (1996). 4 ancestors in all, the oldest K921707 (1992). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK962172 Flexible Mini-FiberscopesRichard Wolf Medical Instruments Corp. · 1996
- 1 generation backK980401 Flexible Fiberscopes and AccessoriesRichard Wolf Medical Instruments Corp. · 1998
- This deviceK992526 Flexible Nasopharyngo-Laryngoscopes, Flexible BronchoscopeRichard Wolf Medical Instruments Corp. · 1999
- Descendant · cites it directly · 1 of its ownK132039 Ergo-Flex Laryngo-Nasopharyngoscope EF-N and EF-N SlimJedmed Instrument Co. · 2014
- Descendant · 2 generations on · 0 of its ownK150248 ORL Video NasoPharyngo-LarngoscopeJedmed Instrument Company · 2015
- Descendant · cites it directly · 0 of its ownK070580 Nasopharyngoscope, BronchoscopeXion GmbH · 2007
Most influential descendants
Showing 3 of 3 · See all- K132039Ergo-Flex Laryngo-Nasopharyngoscope EF-N and EF-N SlimJedmed Instrument Co. · 2014 · cites it directly1descendant
- K150248ORL Video NasoPharyngo-LarngoscopeJedmed Instrument Company · 2015 · 2 generations on0descendants
- K070580Nasopharyngoscope, BronchoscopeXion GmbH · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962172 | Flexible Mini-Fiberscopes | Richard Wolf Medical Instruments Corp. | 1996 | — |
| −1 | K980401 | Flexible Fiberscopes and Accessories | Richard Wolf Medical Instruments Corp. | 1998 | — |
| 0 (this device) | K992526 | Flexible Nasopharyngo-Laryngoscopes, Flexible Bronchoscope | Richard Wolf Medical Instruments Corp. | 1999 | — |
| +1 | K132039 | Ergo-Flex Laryngo-Nasopharyngoscope EF-N and EF-N Slim | Jedmed Instrument Co. | 2014 | — |
| +2 | K150248 | ORL Video NasoPharyngo-Larngoscope | Jedmed Instrument Company | 2015 | — |
| +1 | K070580 | Nasopharyngoscope, Bronchoscope | Xion GmbH | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 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 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? (4)
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 |
|---|---|---|---|
| * | K980401 | Flexible Fiberscopes and AccessoriesSummary page 1…ryngoscope and fiberscope ronchoscope Information on devices to which substantial equivalence is claimed: 510(k) Number Trade or proprietary or model name Manufacturer 1 K980401 1 Flexible fiberscopes and accessories (urology, surgery, 1 Richard Wolf and gynecology) 2 K951196 2 Naso-pharyngo-laryngo-esoph… | 1998 |
| * | K951196 | FNL-10P, Fiber NasoparhyngoscopeSummary page 1…imed: 510(k) Number Trade or proprietary or model name Manufacturer 1 K980401 1 Flexible fiberscopes and accessories (urology, surgery, 1 Richard Wolf and gynecology) 2 K951196 2 Naso-pharyngo-laryngo-esophago fiberscopes FNL-7, 2 Pent /K921707 FNL-10, FNL-13, FNL-15 entax 3 Eg; i?gg / 3 Broncho deluxe fi… | 1995 |
| * | K921707 | Pentax Naso-Pharyngo-Laryngoscope FNL-15P2/15RP2Summary page 1…1 K980401 1 Flexible fiberscopes and accessories (urology, surgery, 1 Richard Wolf and gynecology) 2 K951196 2 Naso-pharyngo-laryngo-esophago fiberscopes FNL-7, 2 Pent /K921707 FNL-10, FNL-13, FNL-15 entax 3 Eg; i?gg / 3 Broncho deluxe fiberscoe FB-10, FB18 3 Pentax 1.0 Description The flexible bronchosc… | 1992 |
| * | — | Broncho deluxe fiberscope FB-10, FB18 Named without a submission number |
What descends from it? (3)
2 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?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K132039 (Jedmed Instrument Co., 2014) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K980401.
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?
The flexible nasopharyngo-laryngoscope and the flexible bronchoscope are used to visualize body cavities via natual passages. The button electrode is used for tissue and vessel coagulation by means of high frequency current under endoscopic view. For examination, diagnosis, and /or therapy in connection with endoscopic accessories / auxiliary instruments through the working channel of the endoscope. This instruement is used in the medical discipline of…
Read the full statement (108 words)
The flexible nasopharyngo-laryngoscope and the flexible bronchoscope are used to
visualize body cavities via natual passages.
The button electrode is used for tissue and vessel coagulation by means of high frequency
current under endoscopic view.
For examination, diagnosis, and /or therapy in connection with endoscopic accessories /
auxiliary instruments through the working channel of the endoscope. This instruement is
used in the medical discipline of ENT (e.g. naso-pharynxngeal cavity - larynx / trachea and
bronchial branch by adequately trained and qualified medical personnel.
IMPORTANT! The product dimensions must correspond to the anatomic conditions, i.e., the
correct flexible nasopharyngo-laryngoscope or flexible bronchoscope must be selected for
the planned intervention.
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/K992526 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992526: Flexible Nasopharyngo-Laryngoscopes, Flexible Bronchoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992526
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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