510(k) · Cleared
ClearedFlexible Hysteroscope with Endosheath System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vision-Sciences, Inc. · HIH Hysteroscope (And Accessories)
Cleared on Nov 16, 2007 as substantially equivalent to K040215 (Vision-Sciences, Inc., 2004) and 2 other predicates after a 207-day review. Its family tree reaches back 7 generations to 1992. 5 later devices descend from it.
- Decided
- Nov 16, 2007
- Review
- 207 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K921244 (1992). 17 ancestors in all, the oldest K843084 (1985). 5 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 6 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 5 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 4 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 3 generations backK031786 Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003
- 2 generations backK040215 Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on…Vision-Sciences, Inc. · 2004
- 1 generation backK053560 Modified Endosheath System for Vsi Flexible CystoscopeVision-Sciences, Inc. · 2006
- This deviceK071127 Flexible Hysteroscope with Endosheath SystemVision-Sciences, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK181909 Luminelle DTx Hysteroscopy SystemUvision360, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK190827 Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile…Uvision360, Inc. · 2019
- Descendant · 3 generations on · 1 of its ownK192278 Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable…Uvision360, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK253905 PrimeSight UltraView SystemCogentix Medical, Inc. · 2026
- Descendant · 4 generations on · 0 of its ownK210512 LUMINELLE DTx SystemUvision360, Inc. · 2021
Most influential descendants
Showing 5 of 5 · See all- K181909Luminelle DTx Hysteroscopy SystemUvision360, Inc. · 2018 · cites it directly3descendants
- K190827Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath RigidUvision360, Inc. · 2019 · 2 generations on2descendants
- K192278Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath…Uvision360, Inc. · 2019 · 3 generations on1descendant
- K253905PrimeSight UltraView SystemCogentix Medical, Inc. · 2026 · cites it directly0descendants
- K210512LUMINELLE DTx SystemUvision360, Inc. · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −6 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −5 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −4 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −3 | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| −2 | K040215 | Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath System | Vision-Sciences, Inc. | 2004 | — |
| −1 | K053560 | Modified Endosheath System for Vsi Flexible Cystoscope | Vision-Sciences, Inc. | 2006 | — |
| 0 (this device) | K071127 | Flexible Hysteroscope with Endosheath System | Vision-Sciences, Inc. | 2007 | — |
| +1 | K181909 | Luminelle DTx Hysteroscopy System | Uvision360, Inc. | 2018 | — |
| +2 | K190827 | Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable… | Uvision360, Inc. | 2019 | — |
| +3 | K192278 | Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable… | Uvision360, Inc. | 2019 | — |
| +1 | K253905 | PrimeSight UltraView System | Cogentix Medical, Inc. | 2026 | — |
| +4 | K210512 | LUMINELLE DTx System | Uvision360, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 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.
Planning a device in HIH? 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 HIH device
- #1 K232003 Endoscopic Video Image Processor, Single-Use…score 16.1 · 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? (4)
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 |
|---|---|---|---|
| * | K040215 | Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath SystemSummary page 1…According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. Predicate Devices: K040215 & K053560 - VSI Flexible Cystoscope with Slide-On EndoSheath® System Manufactured by:… | 2004 |
| * | K053560 | Modified Endosheath System for Vsi Flexible CystoscopeSummary page 1…rding to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. Predicate Devices: K040215 & K053560 - VSI Flexible Cystoscope with Slide-On EndoSheath® System Manufactured by:… | 2006 |
| * | K891451 | Olympus Hyf-P Flexible HysterofiberscopeSummary page 1…Inc. 9 Strathmore Road Natick, MA 01760 Olympus HYF-P Flexible Fiberoptic Hysteroscope (K891451) Olympus HYF-1T Flexible Fiberoptic Hysteroscope Product Description: The device'system described in… | 1989 |
| * | — | Olympus HYF-1T Flexible Fiberoptic Hysteroscope Named without a submission number |
What descends from it? (5)
2 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 15 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
- 3 of the 17 ancestors have a recall of any class.
- Of its descendants, K181909 (Uvision360, Inc., 2018) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K040215.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · HIH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIH
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIH
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIH
1,698in 2025
MAUDE reports naming product code HIH, 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 | 1 | — | 0 | 7 |
| 2008 | 2 | — | 0 | 12 |
| 2009 | 4 | 130 | 0 | 17 |
| 2010 | 4 | 109 | 0 | 31 |
| 2011 | 3 | 118 | 0 | 59 |
| 2012 | 4 | 25 | 0 | 78 |
| 2013 | 5 | 144 | 0 | 111 |
| 2014 | 2 | — | 0 | 125 |
| 2015 | 5 | 52 | 0 | 211 |
| 2016 | 3 | 106 | 0 | 172 |
| 2017 | 2 | — | 0 | 336 |
| 2018 | 8 | 135 | 0 | 182 |
| 2019 | 14 | 91 | 1 | 220 |
| 2020 | 7 | 88 | 0 | 253 |
| 2021 | 4 | 194 | 0 | 193 |
| 2022 | 2 | — | 0 | 289 |
| 2023 | 4 | 200 | 2 | 1,449 |
| 2024 | 6 | 148 | 0 | 1,611 |
| 2025 | 3 | 111 | 0 | 1,698 |
| 2026 | 7 | 168 | 3 | — |
What is it indicated for?
The CST-2000A and Slide-On® EndoSheath® System provides for endoscopic access and examination of the lower urinary tract including the bladder, and using additional accessories, to perform various diagnostic and therapeutic procedures.
The CST-2000A and Slide-On® EndoSheath® System is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and therapeutic/surgical procedures.
Note: The CST-2000A and Slide-On Endosheath System is not indicated for electrosurgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071127: Flexible Hysteroscope with Endosheath System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071127
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