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 Mar 4, 2015 as substantially equivalent to K132009 (Schoelly Fiberoptic GmbH, 2014) after a 70-day review. Its family tree reaches back 3 generations to 1999. 1 later device descends from it.
- Decided
- Mar 4, 2015
- Review
- 70 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K991560 (1999). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK991560 Naso-Laryngo-PharyngoscopeFiber Imaging Technologies, Inc. · 1999
- 2 generations backK083553 Naso-Laryngo-PharyngoscopeSchoelly Imaging, Inc. · 2009
- 1 generation backK132009 Cmos Video Nasopharyngoscope SystemSchoelly Fiberoptic GmbH · 2014
- This deviceK143673 CMOS Video Nasopharyngoscope SystemSchoelly Fiberoptic GmbH · 2015
- Descendant · cites it directly · 0 of its ownK232015 ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope…Atmos Medizintechnik GmbH & Co. KG · 2023
Most influential descendants
Showing 1 of 1 · See all- K232015ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)Atmos Medizintechnik GmbH & Co. KG · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991560 | Naso-Laryngo-Pharyngoscope | Fiber Imaging Technologies, Inc. | 1999 | — |
| −2 | K083553 | Naso-Laryngo-Pharyngoscope | Schoelly Imaging, Inc. | 2009 | — |
| −1 | K132009 | Cmos Video Nasopharyngoscope System | Schoelly Fiberoptic GmbH | 2014 | — |
| 0 (this device) | K143673 | CMOS Video Nasopharyngoscope System | Schoelly Fiberoptic GmbH | 2015 | — |
| +1 | K232015 | ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime… | Atmos Medizintechnik GmbH & Co. KG | 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 |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K132009 | Cmos Video Nasopharyngoscope SystemSummary page 4…Classification Name: EOB – Nasopharyngoscope (flexible or rigid) 21 CFR 874.4760; Class II Premarket Notification: K132009 (Schoelly Fiberoptic GmbH), SE date April 09, 2014 Device Description The Schoelly CMOS Video Nasopharyngoscope System consi… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232015 | ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) | 2023 | 0 |
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 16 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K232015 (Atmos Medizintechnik GmbH & Co. KG, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K132009.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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/K143673 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143673: CMOS Video Nasopharyngoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143673
Report an extraction error
Are you the manufacturer?
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