510(k) · Cleared
ClearedInstrument Exit Point on Touch Surgery™ Aide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · SFE Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation
Cleared on Jun 4, 2026 as substantially equivalent to K250268 (Hypervision Surgical, 2025) after a 174-day review. Its family tree reaches back 14 generations to 1993. 3 of the 41 devices in its family, counting itself, have a Class I recall.
- Decided
- Jun 4, 2026
- Review
- 174 days
- Class
- Class II
- Product code
- SFE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K931154 (1993). 40 ancestors in all, the oldest K843084 (1985). No later device cites it as a predicate yet. 3 of the 41 devices in this family, counting this one, have a Class I recall.
- Root · 14 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 10 generations between
- 3 generations backK192918 Video Laparoscope, Video Processor, Light SourceFujifilm Corporation · 2020
- 2 generations backK203717 Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton · 2021
- 1 generation backK250268 HyperSnap Surgical System (HSS)Hypervision Surgical · 2025
- This deviceK253984 Instrument Exit Point on Touch Surgery™ AideCovidien, LLC · 2026
Show all 14 generations
- Root · 14 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 13 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 12 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 11 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 10 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 9 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 8 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 7 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 6 generations backK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
- 5 generations backK122831 Video System CenterOlympus Medical Systems Corp. · 2012
- 4 generations backK163675 Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. · 2017
- 3 generations backK192918 Video Laparoscope, Video Processor, Light SourceFujifilm Corporation · 2020
- 2 generations backK203717 Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton · 2021
- 1 generation backK250268 HyperSnap Surgical System (HSS)Hypervision Surgical · 2025
- This deviceK253984 Instrument Exit Point on Touch Surgery™ AideCovidien, LLC · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −13 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −12 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −11 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −10 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −9 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −8 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| −7 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| −6 | K112680 | Evis Exera Iii Video System | Olympus Medical Systems Corporation | 2012 | 6 |
| −5 | K122831 | Video System Center | Olympus Medical Systems Corp. | 2012 | — |
| −4 | K163675 | Processor VP-7000, Light Source BL-7000 | Fujifilm Medical System U.S.A., Inc. | 2017 | — |
| −3 | K192918 | Video Laparoscope, Video Processor, Light Source | Fujifilm Corporation | 2020 | — |
| −2 | K203717 | Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 | Fujifilm Corporaton | 2021 | — |
| −1 | K250268 | HyperSnap Surgical System (HSS) | Hypervision Surgical | 2025 | — |
| 0 (this device) | 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 |
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 K250268 HyperSnap Surgical System (HSS)score 16.2 · 13 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K250268 | HyperSnap Surgical System (HSS)Summary page 5…rence Devices Predicate Device Marketing Authorization Product Code HyperSnap Surgical System (HSS) K250268 SFE, FET, MUD Reference Devices Marketing Authorization Product Co… | 2025 |
| † | K242323 | Maestro System (REF100) | 2025 |
| † | K250725 | Hugo™ RAS System | 2025 |
| † | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 7 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 · 8 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 9 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 11 companies; a new generation was cleared every 2.8 years on median.
- 18 of the 40 ancestors have a recall of any class; 3 have a Class I recall.
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. 2026, 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 Instrument exit point application is indicated for use as an adjunct during surgical procedures performed using the Hugo™ Robotic-Assisted Surgery (RAS) system, in accordance with the FDA-cleared indications for use of the Hugo RAS system. The Instrument exit point application does not expand, modify, or replace the indications for use of the Hugo RAS system; refer to the Hugo™ RAS labeling for the applicable indications for use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253984 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253984: Instrument Exit Point on Touch Surgery™ Aide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253984
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026