510(k) · Cleared
ClearedVision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences Dpu-5000/Dpu-5050 Video Processor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vision-Sciences, Inc. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on May 18, 2011 as substantially equivalent to K072073 (Vision-Sciences, Inc., 2007) and 4 other predicates after a 238-day review. Its family tree reaches back 7 generations to 1983. 7 later devices descend from it.
- Decided
- May 18, 2011
- Review
- 238 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K833587 (1983). 55 ancestors in all, the oldest K771218 (1978). 7 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 6 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
- 5 generations backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
- 4 generations backK043395 Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005
- 3 generations backK072879 Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · Recalled
- 2 generations backK082293 Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008
- 1 generation backK093717 C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010
- This deviceK102733 Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology…Vision-Sciences, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK150776 Medrobotics Flex SystemMedrobotics Corporation · 2015
- Descendant · cites it directly · 1 of its ownK123359 OVS1 Video SystemOlive Medical Corp. · 2012
- Descendant · cites it directly · 0 of its ownK181292 PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video…Cogentix Medical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK170453 Medrobotics Flex Robotic SystemMedrobotics Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK152513 8X-10-XXXX Camera SystemSanta Barbara Imaging Systems · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K150776Medrobotics Flex SystemMedrobotics Corporation · 2015 · cites it directly1descendant
- K123359OVS1 Video SystemOlive Medical Corp. · 2012 · cites it directly1descendant
- K181292PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video ProcessorCogentix Medical, Inc. · 2018 · cites it directly0descendants
- K170453Medrobotics Flex Robotic SystemMedrobotics Corporation · 2017 · 2 generations on0descendants
- K1525138X-10-XXXX Camera SystemSanta Barbara Imaging Systems · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K833587 | Disposable Arthroscopy Blade | Dyonics, Inc. | 1983 | — |
| −6 | K900070 | Modified Uses of the Arthroscopic Surgical System | Dyonics, Inc. | 1990 | — |
| −5 | K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | 1997 | — |
| −4 | K043395 | Smith & Nephew Videoarthroscope | Smith & Nephew, Inc. | 2005 | — |
| −3 | K072879 | Innervue Diagnostic Scope System | Biomet Orthopedics, Inc. | 2008 | 2 |
| −2 | K082293 | Surgview Integrated Visualization System | Biovision Technologies, LLC | 2008 | — |
| −1 | K093717 | C-Mor Visualization Device | Axis Surgical Technologies, Inc. | 2010 | — |
| 0 (this device) | K102733 | Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology… | Vision-Sciences, Inc. | 2011 | — |
| +1 | K150776 | Medrobotics Flex System | Medrobotics Corporation | 2015 | — |
| +1 | K123359 | OVS1 Video System | Olive Medical Corp. | 2012 | — |
| +1 | K181292 | PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor | Cogentix Medical, Inc. | 2018 | — |
| +2 | K170453 | Medrobotics Flex Robotic System | Medrobotics Corporation | 2017 | — |
| +2 | K152513 | 8X-10-XXXX Camera System | Santa Barbara Imaging Systems | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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? (5)
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 |
|---|---|---|---|
| * | K072073 | Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System…Summary page 1…Modified Flexible ENT Scopes with Digital Video Processor and Disposable EndoSheath® Technology (K072073) Avis Surgical Technologies, Inc.: C-MOR Visualization System… | 2007 |
| * | K093717 | C-Mor Visualization DeviceSummary page 1…th® Technology (K072073) Avis Surgical Technologies, Inc.: C-MOR Visualization System (K0937 17) Biomet lnnerVueTm Diagnostic Scope System (K072879)… | 2010 |
| * | K072879 | Innervue Diagnostic Scope SystemSummary page 1…Inc.: C-MOR Visualization System (K0937 17) Biomet lnnerVueTm Diagnostic Scope System (K072879) Smith & Nephew Arthroscope (K043395) SpineVi… | 2008 |
| * | K043395 | Smith & Nephew VideoarthroscopeSummary page 1…7 17) Biomet lnnerVueTm Diagnostic Scope System (K072879) Smith & Nephew Arthroscope (K043395) SpineView SpineVu Endoscopic Spine System (SESS%) and… | 2005 |
| * | K081051 | Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSummary page 1…ope (K043395) SpineView SpineVu Endoscopic Spine System (SESS%) and SpineVu MiniScope (K081051) Common/Usual Name: Flexible video endoscopes with sheaths and accessories Product Codes:… | 2008 |
What descends from it? (7)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 5 of the 55 ancestors have a recall of any class.
- Of its descendants, K150776 (Medrobotics Corporation, 2015) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K072073.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The flexible ENT-5000 Video ENT Scope with EndoSheath® Technology is intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages; and for use in diagnostic arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.
The digital video processor is intended for use with the VSi flexible video scope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102733 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102733: Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences Dpu-5000/Dpu-5050 Video Processor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102733
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