510(k) · Cleared
ClearedNasopharyngoscope, Bronchoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xion GmbH · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Jun 13, 2007 as substantially equivalent to K992526 (Richard Wolf Medical Instruments Corp., 1999) after a 104-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Jun 13, 2007
- Review
- 104 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K962172 (1996). 5 ancestors in all, the oldest K921707 (1992). No later device cites it as a predicate yet.
- Root · 3 generations backK962172 Flexible Mini-FiberscopesRichard Wolf Medical Instruments Corp. · 1996
- 2 generations backK980401 Flexible Fiberscopes and AccessoriesRichard Wolf Medical Instruments Corp. · 1998
- 1 generation backK992526 Flexible Nasopharyngo-Laryngoscopes, Flexible BronchoscopeRichard Wolf Medical Instruments Corp. · 1999
- This deviceK070580 Nasopharyngoscope, BronchoscopeXion GmbH · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962172 | Flexible Mini-Fiberscopes | Richard Wolf Medical Instruments Corp. | 1996 | — |
| −2 | K980401 | Flexible Fiberscopes and Accessories | Richard Wolf Medical Instruments Corp. | 1998 | — |
| −1 | K992526 | Flexible Nasopharyngo-Laryngoscopes, Flexible Bronchoscope | Richard Wolf Medical Instruments Corp. | 1999 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K992526 | Flexible Nasopharyngo-Laryngoscopes, Flexible BronchoscopeSummary page 1…lexible bronchoscope to which Equivalence is Richard Wolf Medical Instruments Corp. Claimed: (Premarket notification K992526) Description: Flexible nasopharyngoscopes with or without a working channel are built… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K992526.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
Nasopharyngoscopes are intended to examine or treat the nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and the vocal chords.
They allow the recognition of anomalies in the tissue of the accessible organs. The EF-N 14 and EF-N 14S models with their working channel allow the insertion of an instrument to carry out a biopsy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070580 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070580: Nasopharyngoscope, Bronchoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070580
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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