510(k) · Cleared
ClearedCmos Video Nasopharyngoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schoelly Fiberoptic GmbH · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Apr 9, 2014 as substantially equivalent to K103467 (KARL STORZ Endoscopy-America, Inc., 2012) and 1 other predicate after a 282-day review. Its family tree reaches back 2 generations to 1999. 3 later devices descend from it.
- Decided
- Apr 9, 2014
- Review
- 282 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K991560 (1999). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK991560 Naso-Laryngo-PharyngoscopeFiber Imaging Technologies, Inc. · 1999
- 1 generation backK083553 Naso-Laryngo-PharyngoscopeSchoelly Imaging, Inc. · 2009
- This deviceK132009 Cmos Video Nasopharyngoscope SystemSchoelly Fiberoptic GmbH · 2014
- Descendant · cites it directly · 1 of its ownK143673 CMOS Video Nasopharyngoscope SystemSchoelly Fiberoptic GmbH · 2015
- Descendant · 2 generations on · 0 of its ownK232015 ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope…Atmos Medizintechnik GmbH & Co. KG · 2023
- Descendant · cites it directly · 0 of its ownK222587 PatCom Distal Chip EndoscopeH&A Mui Enterprises, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See all- K143673CMOS Video Nasopharyngoscope SystemSchoelly Fiberoptic GmbH · 2015 · cites it directly1descendant
- K232015ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)Atmos Medizintechnik GmbH & Co. KG · 2023 · 2 generations on0descendants
- K222587PatCom Distal Chip EndoscopeH&A Mui Enterprises, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991560 | Naso-Laryngo-Pharyngoscope | Fiber Imaging Technologies, Inc. | 1999 | — |
| −1 | K083553 | Naso-Laryngo-Pharyngoscope | Schoelly Imaging, Inc. | 2009 | — |
| 0 (this device) | K132009 | Cmos Video Nasopharyngoscope System | Schoelly Fiberoptic GmbH | 2014 | — |
| +1 | K143673 | CMOS Video Nasopharyngoscope System | Schoelly Fiberoptic GmbH | 2015 | — |
| +2 | K232015 | ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime… | Atmos Medizintechnik GmbH & Co. KG | 2023 | — |
| +1 | K222587 | PatCom Distal Chip Endoscope | H&A Mui Enterprises, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2023 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103467 | Cmos Video Rhino-Laryngoscope System Model 11101CMSummary page 1…FOB3 - Nasopharyngoseope (flexible or rigid) 21 CFR 874.4760; Class 11 Premarket Notification: K 103467 (Karl Storz Endoscopy-America, Inc.), SE date June 28, 2012 Predicate Device Name: Schoelly Naso-Laryngo-Pha… | 2012 |
| * | K083553 | Naso-Laryngo-PharyngoscopeSummary page 1…E013 - Nasopharyngoscope (flexible or rigid) 21 CFR 874.4760; Class 11 Premarket Notification: K083553 (Schoelly Imaging, Inc.), SE date January 16. 2009 Device Description The Schoelly CMOS Video Nasopharyngoscope System… | 2009 |
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 15 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K143673 (Schoelly Fiberoptic GmbH, 2015) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K103467.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
The Schoelly CMOS Video Nasopharyngoscope System may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique. The endoscope is used for endoscopic diagnosis within the nasal lumens and airway anatomy, and is intended to provide visualization via a video monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132009: Cmos Video Nasopharyngoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132009
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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