510(k) · Cleared
ClearedAccessories for Endoscopes for Sinus Surgery
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Richards, Inc. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Jul 26, 1993 after a 38-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jul 26, 1993
- Review
- 38 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK932988 Accessories for Endoscopes for Sinus SurgerySmith & Nephew Richards, Inc. · 1993
- Descendant · cites it directly · 3 of its ownK981751 Sinuscope and AccessoriesHenke Sass Wolf of America, Inc. · 1998
- Descendant · 2 generations on · 2 of its ownK032822 Asap Sinuscope…Asap Endoscopic Products GmbH · 2004
- Descendant · 3 generations on · 1 of its ownK082667 Visionsense Stereoscopic Vision System (VS System)Visionsense, Ltd. · 2008
- Descendant · 4 generations on · 0 of its ownK162410 TIPCAM 1S 3D SystemKarl Storz Endoscopy America, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK990213 Hydraclear Pump Console, Hydraclear Power Supplly, Hydraclear…Gyrus Ent LLC · 1999
Most influential descendants
Showing 5 of 5 · See all- K981751Sinuscope and AccessoriesHenke Sass Wolf of America, Inc. · 1998 · cites it directly3descendants
- K032822Asap Sinuscope…Asap Endoscopic Products GmbH · 2004 · 2 generations on2descendants
- K082667Visionsense Stereoscopic Vision System (VS System)Visionsense, Ltd. · 2008 · 3 generations on1descendant
- K162410TIPCAM 1S 3D SystemKarl Storz Endoscopy America, Inc. · 2017 · 4 generations on0descendants
- K990213Hydraclear Pump Console, Hydraclear Power Supplly, Hydraclear Footswitch, Hydraclear…Gyrus Ent LLC · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K932988 | Accessories for Endoscopes for Sinus Surgery | Smith & Nephew Richards, Inc. | 1993 | — |
| +1 | K981751 | Sinuscope and Accessories | Henke Sass Wolf of America, Inc. | 1998 | — |
| +2 | K032822 | Asap Sinuscope… | Asap Endoscopic Products GmbH | 2004 | — |
| +3 | K082667 | Visionsense Stereoscopic Vision System (VS System) | Visionsense, Ltd. | 2008 | — |
| +4 | K162410 | TIPCAM 1S 3D System | Karl Storz Endoscopy America, Inc. | 2017 | — |
| +1 | K990213 | Hydraclear Pump Console, Hydraclear Power Supplly, Hydraclear Footswitch… | Gyrus Ent LLC | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
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?
- Of its descendants, K981751 (Henke Sass Wolf of America, Inc., 1998) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/K932988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K932988: Accessories for Endoscopes for Sinus Surgery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932988
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026