510(k) · Cleared
ClearedATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atmos Medizintechnik GmbH & Co. KG · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Aug 3, 2023 as substantially equivalent to K143673 (Schoelly Fiberoptic GmbH, 2015) after a 28-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Aug 3, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K991560 (1999). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK991560 Naso-Laryngo-PharyngoscopeFiber Imaging Technologies, Inc. · 1999
- 3 generations backK083553 Naso-Laryngo-PharyngoscopeSchoelly Imaging, Inc. · 2009
- 2 generations backK132009 Cmos Video Nasopharyngoscope SystemSchoelly Fiberoptic GmbH · 2014
- 1 generation backK143673 CMOS Video Nasopharyngoscope SystemSchoelly Fiberoptic GmbH · 2015
- This deviceK232015 ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope…Atmos Medizintechnik GmbH & Co. KG · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K991560 | Naso-Laryngo-Pharyngoscope | Fiber Imaging Technologies, Inc. | 1999 | — |
| −3 | K083553 | Naso-Laryngo-Pharyngoscope | Schoelly Imaging, Inc. | 2009 | — |
| −2 | K132009 | Cmos Video Nasopharyngoscope System | Schoelly Fiberoptic GmbH | 2014 | — |
| −1 | K143673 | CMOS Video Nasopharyngoscope System | Schoelly Fiberoptic GmbH | 2015 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K143673 | CMOS Video Nasopharyngoscope SystemSummary page 4…Schoelly Fiberoptic GmbH Predicate Trade Name: Schoelly CMOS Video Nasopharyngoscope System Predicate 510(k): K143673 Device Product Code: EOB Device Description The ATMOS Scope is a flexible nasopharyngo laryngoscope f… | 2015 |
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 24 years and passes through 4 companies; a new generation was cleared every 8.4 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
ATMOS Scope is used for endoscopic diagnosis within the nasal lumens and airway anatomy and is intended to provide visualization via a monitor. The ATMOS Scope may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232015: ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232015
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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