510(k) · Cleared
ClearedHyperSnap Surgical System (HSS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hypervision Surgical · SFE Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation
Cleared on Jun 24, 2025 as substantially equivalent to K203717 (Fujifilm Corporaton, 2021) after a 145-day review. Its family tree reaches back 13 generations to 1993. 3 of the 41 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jun 24, 2025
- Review
- 145 days
- Class
- Class II
- Product code
- SFE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K931154 (1993). 39 ancestors in all, the oldest K843084 (1985). 1 later device descends from it, 1 citing it directly. 3 of the 41 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 9 generations between
- 3 generations backK163675 Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. · 2017
- 2 generations backK192918 Video Laparoscope, Video Processor, Light SourceFujifilm Corporation · 2020
- 1 generation backK203717 Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton · 2021
- This deviceK250268 HyperSnap Surgical System (HSS)Hypervision Surgical · 2025
- Descendant · cites it directly · 0 of its ownK253984 Instrument Exit Point on Touch Surgery™ AideCovidien, LLC · 2026
Show all 13 generations
- Root · 13 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 12 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 11 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 10 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 9 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 8 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 7 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 6 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 5 generations backK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
- 4 generations backK122831 Video System CenterOlympus Medical Systems Corp. · 2012
- 3 generations backK163675 Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. · 2017
- 2 generations backK192918 Video Laparoscope, Video Processor, Light SourceFujifilm Corporation · 2020
- 1 generation backK203717 Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton · 2021
- This deviceK250268 HyperSnap Surgical System (HSS)Hypervision Surgical · 2025
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K253984Instrument Exit Point on Touch Surgery™ AideCovidien, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −12 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −11 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −10 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −9 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −8 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −7 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| −6 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| −5 | K112680 | Evis Exera Iii Video System | Olympus Medical Systems Corporation | 2012 | 6 |
| −4 | K122831 | Video System Center | Olympus Medical Systems Corp. | 2012 | — |
| −3 | K163675 | Processor VP-7000, Light Source BL-7000 | Fujifilm Medical System U.S.A., Inc. | 2017 | — |
| −2 | K192918 | Video Laparoscope, Video Processor, Light Source | Fujifilm Corporation | 2020 | — |
| −1 | K203717 | Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 | Fujifilm Corporaton | 2021 | — |
| 0 (this device) | K250268 | HyperSnap Surgical System (HSS) | Hypervision Surgical | 2025 | — |
| +1 | K253984 | Instrument Exit Point on Touch Surgery™ Aide | Covidien, LLC | 2026 | — |
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 | 3 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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.
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 SFE device
- #1 K253984 Instrument Exit Point on Touch Surgery™ Aidescore 15.4 · 14 generations · no Class I recall
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.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253984 | Instrument Exit Point on Touch Surgery™ Aide | 2026 | 0 |
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 · 6 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 · 7 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 8 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 10 companies; a new generation was cleared every 2.8 years on median.
- 18 of the 39 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K253984 (Covidien, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K203717.
How does its category compare?
All SFE devicesSFE Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SFE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SFE
Too few SFE 510(k)s in any year since 2007 to give a median.
Recalls per year · SFE
No recall names SFE since 2007.
Adverse event reports per year · SFE
No MAUDE report names SFE since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The HyperSnap Surgical System is a real-time video camera system utilising computational hyperspectral imaging in the visible spectrum. The system is intended to be used intraoperatively to relay a standard RGB video feed used for visualisation alongside corresponding tissue oxygenation information presented as a corresponding two-dimensional real-time video feed. The system is intended for use as an adjunctive monitor of the haemoglobin oxygen…
Read the full statement (131 words)
The HyperSnap Surgical System is a real-time video camera system utilising computational hyperspectral imaging in the visible spectrum. The system is intended to be used intraoperatively to relay a standard RGB video feed used for visualisation alongside corresponding tissue oxygenation information presented as a corresponding two-dimensional real-time video feed.
The system is intended for use as an adjunctive monitor of the haemoglobin oxygen saturation of blood (StO2) in the superficial tissue in the surgical field of view.
The HyperSnap Surgical System may help identify patients at risk of tissue ischaemia. The system is indicated for use in all populations for open and minimally invasive general surgical applications utilising compatible surgical telescopes (exoscopes and rigid endoscopes).
The prospective clinical value of measurements made with StO2 has not been demonstrated in disease states.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250268 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250268: HyperSnap Surgical System (HSS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250268
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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