510(k) · Cleared
ClearedSinuscope and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Henke Sass Wolf of America, Inc. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Aug 13, 1998 as substantially equivalent to K932988 (Smith & Nephew Richards, Inc., 1993) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1988. 3 later devices descend from it.
- Decided
- Aug 13, 1998
- Review
- 87 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K874215 (1988). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK874215 Endoscopes for Sinus SurgeryRichards Medical Co., Inc. · 1988
- This deviceK981751 Sinuscope and AccessoriesHenke Sass Wolf of America, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK032822 Asap Sinuscope…Asap Endoscopic Products GmbH · 2004
- Descendant · 2 generations on · 1 of its ownK082667 Visionsense Stereoscopic Vision System (VS System)Visionsense, Ltd. · 2008
- Descendant · 3 generations on · 0 of its ownK162410 TIPCAM 1S 3D SystemKarl Storz Endoscopy America, Inc. · 2017
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 | K874215 | Endoscopes for Sinus Surgery | Richards Medical Co., Inc. | 1988 | — |
| 0 (this device) | K981751 | Sinuscope and Accessories | Henke Sass Wolf of America, Inc. | 1998 | — |
| +1 | K032822 | Asap Sinuscope… | Asap Endoscopic Products GmbH | 2004 | — |
| +2 | K082667 | Visionsense Stereoscopic Vision System (VS System) | Visionsense, Ltd. | 2008 | — |
| +3 | K162410 | TIPCAM 1S 3D System | Karl Storz Endoscopy America, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K932988 | Accessories for Endoscopes for Sinus SurgerySummary page 1…rincipals and intended uses as many of the competitive sinuscopes and accessories already in commercial distribution Predicate Devices: Smith& Nephew Richards Sinuscope K932988, Richards Medical Company Endoscopes for Sinus Surgery K874215(manufactured by HENKE SASS WOLF, GmbH) Comparison of Technologica… | 1993 |
| * | K874215 | Endoscopes for Sinus SurgerySummary page 1…es and accessories already in commercial distribution Predicate Devices: Smith& Nephew Richards Sinuscope K932988, Richards Medical Company Endoscopes for Sinus Surgery K874215(manufactured by HENKE SASS WOLF, GmbH) Comparison of Technological Characteristics: The sinuscope material and design is identic… | 1988 |
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 |
|---|---|---|---|
| K032822 | Asap Sinuscope… | 2004 | 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.
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 HENKE-SASS WOLF of America Inc., Sinuscope is intended to
provide the physician with a means for endoscopic diagnostic and
therapeutic sinus surgical procedures. The HENKE SASS WOLF of
America Inc. Sinuscope Accessories will include Sheaths - to
establish portals for visualization and surgical access and the
Suction/Irrigation Handle - to remove debris and body fluids
from the surgical site and to provide irrigation of the site
with a sterile solution such as saline water.
The Sinuscope and accessories are indicated for use in, but not
t limited to such procedures as examination of sinus passages and
cavities, removal of abnormal growths such as polyps and
facio-plastic surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981751 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981751: Sinuscope and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981751
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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