510(k) · Cleared
ClearedHTx Disposable Hysteroscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acuvu, Inc. · HIH Hysteroscope (And Accessories)
Cleared on Sep 15, 2021 as substantially equivalent to K180096 (Acuvu, Inc., 2018) after a 145-day review. Its family tree reaches back 1 generation to 2018. 2 later devices descend from it.
- Decided
- Sep 15, 2021
- Review
- 145 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K180096 (2018). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK180096 GDT-1000 SystemAcuvu, Inc. · 2018
- This deviceK211227 HTx Disposable Hysteroscope SystemAcuvu, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK240401 ClearVision Single Use Hysteroscope & Image Processing System…Origyn Medical Technology (Hangzhou) Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK231260 HTx Disposable Hysteroscope SystemSuzhou AcuVu Medical Technology Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K180096 | GDT-1000 System | Acuvu, Inc. | 2018 | — |
| 0 (this device) | K211227 | HTx Disposable Hysteroscope System | Acuvu, Inc. | 2021 | — |
| +1 | K240401 | ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001… | Origyn Medical Technology (Hangzhou) Co., Ltd. | 2024 | — |
| +1 | K231260 | HTx Disposable Hysteroscope System | Suzhou AcuVu Medical Technology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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.
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? (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 |
|---|---|---|---|
| * | K180096 | GDT-1000 SystemSummary page 4…tory Class: Class II Product Code HIH (Hysteroscope and Accessories) Panel: Obstetrics/Gynecology Predicate Device: AcuVu GDT-1000 (K180096) The predicate device has not been subject to a design-related recall. Indications for Use HTx disposable hysteroscope system i… | 2018 |
What descends from it? (2)
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?
- Its one ancestor has no recall.
- Of its descendants, K240401 (Origyn Medical Technology (Hangzhou) Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
HTx disposable hysteroscope system is intended to be used for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211227: HTx Disposable Hysteroscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211227
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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