510(k) · Cleared
ClearedSchoelly Sinuscope
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 Jan 27, 2015 as substantially equivalent to K965233 (Xomed, Inc., 1997) after a 166-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it.
- Decided
- Jan 27, 2015
- Review
- 166 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K965233 (1997). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK965233 Sharpsite ACXomed, Inc. · 1997
- This deviceK142249 Schoelly SinuscopeSchoelly Fiberoptic GmbH · 2015
- Descendant · cites it directly · 2 of its ownK191102 Precision S 4K SinuscopeStryker · 2019
- Descendant · 2 generations on · 0 of its ownK253602 Precision S 4K SinuscopeStryker Endoscopy · 2026
- Descendant · 2 generations on · 0 of its ownK241731 Outlook Surgical Versa One System (8900139)Resnent, LLC · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K965233 | Sharpsite AC | Xomed, Inc. | 1997 | — |
| 0 (this device) | K142249 | Schoelly Sinuscope | Schoelly Fiberoptic GmbH | 2015 | — |
| +1 | K191102 | Precision S 4K Sinuscope | Stryker | 2019 | — |
| +2 | K253602 | Precision S 4K Sinuscope | Stryker Endoscopy | 2026 | — |
| +2 | K241731 | Outlook Surgical Versa One System (8900139) | Resnent, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K965233 | Sharpsite ACSummary page 4…se Endoscope Classification Name: EOB – Nasopharyngoscope (flexible or rigid) 21 CFR 874.4760; Class II Premarket Notification: K965233, Medtronic Xomed Inc., SE date April 4, 1997 Device Description The Schoelly Sinuscope is a rigid reusable endoscope for visuali… | 1997 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191102 | Precision S 4K Sinuscope | 2019 | 2 |
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?
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 Sinuscope is intended for use in otolaryngology and Head and Neck procedures, including rhinology, and endoscopic plastic and reconstructive surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142249: Schoelly Sinuscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142249
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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