510(k) · Cleared
ClearedSPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Nov 20, 2015 as substantially equivalent to K123365 (Olympus Medical Systems Corp., 2013) after a 263-day review. Its family tree reaches back 10 generations to 1993. 3 of the 45 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it.
- Decided
- Nov 20, 2015
- Review
- 263 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K931154 (1993). 37 ancestors in all, the oldest K843084 (1985). 7 later devices descend from it, 2 citing it directly. 3 of the 45 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 6 generations between
- 3 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 2 generations backK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
- 1 generation backK123365 Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp. · 2013
- This deviceK150525 SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU…KARL STORZ Endoscopy-America, Inc. · 2015
- Descendant · cites it directly · 5 of its ownK201526 TIPCAM1 Rubina Video Endoscope SystemKarl Storz Endoscopy America · 2020
- Descendant · 2 generations on · 4 of its ownK223759 Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc. · 2023
- Descendant · 3 generations on · 3 of its ownK233451 Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc. · 2024
- Descendant · 4 generations on · 2 of its ownK241361 Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc. · 2024
- Descendant · 5 generations on · 1 of its ownK250728 Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc. · 2025
Show all 10 generations
- Root · 10 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 9 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 8 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 7 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 6 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 5 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 4 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 3 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 2 generations backK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
- 1 generation backK123365 Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp. · 2013
- This deviceK150525 SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU…KARL STORZ Endoscopy-America, Inc. · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K201526TIPCAM1 Rubina Video Endoscope SystemKarl Storz Endoscopy America · 2020 · cites it directly5descendants
- K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc. · 2023 · 2 generations on4descendants
- K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc. · 2024 · 3 generations on3descendants
- K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc. · 2024 · 4 generations on2descendants
- K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc. · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −9 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −8 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −7 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −6 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −5 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −4 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| −3 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| −2 | K112680 | Evis Exera Iii Video System | Olympus Medical Systems Corporation | 2012 | 6 |
| −1 | K123365 | Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190 | Olympus Medical Systems Corp. | 2013 | — |
| 0 (this device) | K150525 | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link | KARL STORZ Endoscopy-America, Inc. | 2015 | — |
| +1 | K201526 | TIPCAM1 Rubina Video Endoscope System | Karl Storz Endoscopy America | 2020 | — |
| +2 | K223759 | Arthrex SynergyID Endoscopic Imaging System | Arthex, Inc. | 2023 | — |
| +3 | K233451 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | 2024 | — |
| +4 | K241361 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | 2024 | — |
| +5 | K250728 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 1 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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.
3 devices in this family have a Class I recall. 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 HET device
- #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 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 |
|---|---|---|---|
| * | K123365 | Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Summary page 4…HET, GCJ, FGB Regulation: 21 CFR 884.1720 Predicate Device(s): ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE SYSTEM (K123365) Device Description: The SPIES 3D System is intended for use during diagnostic and/or surg… | 2013 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 3 generations back · ◆ on the line of descent in FIG. 16 Class I recalls
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 5 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- 18 of the 37 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K201526 (Karl Storz Endoscopy America, 2020) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K123365.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 2025
MAUDE reports naming product code HET, 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 | 0 | — | 0 | 181 |
| 2008 | 3 | 176 | 4 | 359 |
| 2009 | 1 | — | 1 | 403 |
| 2010 | 1 | — | 0 | 214 |
| 2011 | 2 | — | 0 | 417 |
| 2012 | 2 | — | 0 | 1,118 |
| 2013 | 2 | — | 0 | 1,035 |
| 2014 | 0 | — | 0 | 175 |
| 2015 | 2 | — | 1 | 124 |
| 2016 | 0 | — | 0 | 205 |
| 2017 | 2 | — | 0 | 89 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 2 | — | 0 | 49 |
| 2021 | 4 | 269 | 0 | 132 |
| 2022 | 1 | — | 1 | 216 |
| 2023 | 0 | — | 4 | 824 |
| 2024 | 0 | — | 0 | 3,496 |
| 2025 | 2 | — | 0 | 4,513 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
3D TIPCAM®1: The Rigid Videoendoscope is intended to be used together with the camera control unit is for use during diagnostic and/or surgical procedures when endoscopic video assistance is required. For use in all endoscopy and endoscopic surgery within the peritoneal and thoracic cavity, including gynecological and urological anatomy.
IMAGE1 SPIES 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/K150525 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150525: SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150525
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