510(k) · Cleared
ClearedTIPCAM 1S 3D System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz Endoscopy America, Inc. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Mar 2, 2017 as substantially equivalent to K082667 (Visionsense, Ltd., 2008) after a 185-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- Mar 2, 2017
- Review
- 185 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K874215 (1988). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK874215 Endoscopes for Sinus SurgeryRichards Medical Co., Inc. · 1988
- 3 generations backK981751 Sinuscope and AccessoriesHenke Sass Wolf of America, Inc. · 1998
- 2 generations backK032822 Asap Sinuscope…Asap Endoscopic Products GmbH · 2004
- 1 generation backK082667 Visionsense Stereoscopic Vision System (VS System)Visionsense, Ltd. · 2008
- This deviceK162410 TIPCAM 1S 3D SystemKarl Storz Endoscopy America, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K874215 | Endoscopes for Sinus Surgery | Richards Medical Co., Inc. | 1988 | — |
| −3 | K981751 | Sinuscope and Accessories | Henke Sass Wolf of America, Inc. | 1998 | — |
| −2 | K032822 | Asap Sinuscope… | Asap Endoscopic Products GmbH | 2004 | — |
| −1 | K082667 | Visionsense Stereoscopic Vision System (VS System) | Visionsense, Ltd. | 2008 | — |
| 0 (this device) | 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 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2008 | 2 | 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 |
|---|---|---|---|
| * | K082667 | Visionsense Stereoscopic Vision System (VS System)Summary page 4…: Endoscopic Camera System Product Code: EOB Regulation: 21 CFR 874.4760 Predicate Device(s): VSII Visionsense Stereoscopic Vision System (K082667) **The above predicate has not been subject to any recall** Reference Device SPIES 3D System (… | 2008 |
| † | K150525 | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link | 2015 |
| † | K945788 | Karl Storz Rigid Telescopes for Ent Endoscopic Procedures | 1995 |
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 29 years and passes through 5 companies; a new generation was cleared every 8.3 years on median.
- 1 of the 9 ancestors has a recall of any class.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
TIPCAM 1S 3D: The Rigid Videoendoscope is intended to be used together with the camera control unit for use to visualize the nasal cavity and nasal pharynx during diagnostic and therapeutic procedures.
IMAGE1 S is a camera control unit (CCU) for use with camera heads or videoendoscopes for the visualization and documentation of endoscopic and microscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162410 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162410: TIPCAM 1S 3D System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162410
Report an extraction error
Are you the manufacturer?
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