510(k) · Cleared
ClearedAsap Sinuscope 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asap Endoscopic Products GmbH · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Jan 8, 2004 as substantially equivalent to K981751 (Henke Sass Wolf of America, Inc., 1998) after a 120-day review. Its family tree reaches back 2 generations to 1988. 2 later devices descend from it.
- Decided
- Jan 8, 2004
- Review
- 120 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K874215 (1988). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK874215 Endoscopes for Sinus SurgeryRichards Medical Co., Inc. · 1988
- 1 generation backK981751 Sinuscope and AccessoriesHenke Sass Wolf of America, Inc. · 1998
- This deviceK032822 Asap Sinuscope…Asap Endoscopic Products GmbH · 2004
- Descendant · cites it directly · 1 of its ownK082667 Visionsense Stereoscopic Vision System (VS System)Visionsense, Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK162410 TIPCAM 1S 3D SystemKarl Storz Endoscopy America, Inc. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K874215 | Endoscopes for Sinus Surgery | Richards Medical Co., Inc. | 1988 | — |
| −1 | K981751 | Sinuscope and Accessories | Henke Sass Wolf of America, Inc. | 1998 | — |
| 0 (this device) | K032822 | Asap Sinuscope… | Asap Endoscopic Products GmbH | 2004 | — |
| +1 | K082667 | Visionsense Stereoscopic Vision System (VS System) | Visionsense, Ltd. | 2008 | — |
| +2 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K981751 | Sinuscope and AccessoriesSummary page 1…-0046-00, 10-0086-00, 10-0047-00 Common name: Sinuscope Predicate device name: Sinuscope (K 981751) Classification name: Nasopharyngoscope (flexible or rigid); 77-EOB Code of Federal Regulations (CFR) number:… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082667 | Visionsense Stereoscopic Vision System (VS System) | 2008 | 1 |
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 10.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K082667 (Visionsense, Ltd., 2008) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
The asap ENT endoscope is intended to provide the physician with a means for direct viewing of the nasal cavity and nasal pharynx by providing illumination and visualization of these regions during various diagnostic and therapeutic procedures.
The asap ENT endoscope is reusable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032822 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032822: Asap Sinuscope 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032822
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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