510(k) · Cleared
ClearedHysteroscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai AnQing Medical Instrument Co., Ltd. · HIH Hysteroscope (And Accessories)
Cleared on May 10, 2019 as substantially equivalent to K171113 (Lina Medical Aps, 2018) after a 332-day review. Its family tree reaches back 12 generations to 1993. 1 of the 38 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- May 10, 2019
- Review
- 332 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K931154 (1993). 35 ancestors in all, the oldest K791182 (1979). 2 later devices descend from it, 1 citing it directly. 1 of the 38 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 8 generations between
- 3 generations backK123151 Endosee Model 8000 U-ScopeEndosee Corp · 2013
- 2 generations backK132384 U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation · 2014
- 1 generation backK171113 LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA…Lina Medical Aps · 2018
- This deviceK181545 Hysteroscope SystemShanghai AnQing Medical Instrument Co., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK210270 Medical Endoscope Image Processing SystemJiangsu Jiyuan Medical Technology Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK252793 ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI®…Jiangsu Jiyuan Medical Technology Co., Ltd. · 2025
Show all 12 generations
- Root · 12 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 11 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 10 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 9 generations backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- 8 generations backK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- 7 generations backK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
- 6 generations backK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- 5 generations backK072594 Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc. · 2007
- 4 generations backK092278 Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc. · 2009
- 3 generations backK123151 Endosee Model 8000 U-ScopeEndosee Corp · 2013
- 2 generations backK132384 U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation · 2014
- 1 generation backK171113 LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA…Lina Medical Aps · 2018
- This deviceK181545 Hysteroscope SystemShanghai AnQing Medical Instrument Co., Ltd. · 2019
Class I recalls in this family
- K912120 Urf-P2 Ureterorenofiberscope/Choledochofiberscope7 generations back · 1991
Most influential descendants
Showing 2 of 2 · See all- K210270Medical Endoscope Image Processing SystemJiangsu Jiyuan Medical Technology Co., Ltd. · 2021 · cites it directly1descendant
- K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope…Jiangsu Jiyuan Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −11 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −10 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −9 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| −8 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| −7 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
| −6 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| −5 | K072594 | Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope System | Gyrus Acmi, Inc. | 2007 | — |
| −4 | K092278 | Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4 | Gyrus Acmi, Inc. | 2009 | — |
| −3 | K123151 | Endosee Model 8000 U-Scope | Endosee Corp | 2013 | — |
| −2 | K132384 | U-Scope 8000 System with HSC+Emb Cannula | Endosec Corporation | 2014 | — |
| −1 | K171113 | LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope… | Lina Medical Aps | 2018 | — |
| 0 (this device) | K181545 | Hysteroscope System | Shanghai AnQing Medical Instrument Co., Ltd. | 2019 | — |
| +1 | K210270 | Medical Endoscope Image Processing System | Jiangsu Jiyuan Medical Technology Co., Ltd. | 2021 | — |
| +2 | K252793 | ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use… | Jiangsu Jiyuan Medical Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 1 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 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.
1 device in this family has 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 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 |
|---|---|---|---|
| * | K171113 | LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI…Summary page 4…Hysteroscope Classification: 21 CFR 884.1690 Hysteroscope and Accessories Product Code: HIH, Hysteroscope and Accessories Premarket Notification: K171113 The predicate device has not been subject to a design-related recall. IV. Device description The Hysteroscope System consists o… | 2018 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210270 | Medical Endoscope Image Processing System | 2021 | 1 |
Has anything in its family been recalled? (1 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.
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 7 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- 9 of the 35 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K210270 (Jiangsu Jiyuan Medical Technology Co., Ltd., 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K171113.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Hysteroscope System is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. Note: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery. Generally recognized indications for diagnostic hysteroscopy include: • Abnormal bleeding • Infertility and pregnancy wastage • Evaluation of abnormal…
Read the full statement (107 words)
The Hysteroscope System is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
Note: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery.
Generally recognized indications for diagnostic hysteroscopy include:
• Abnormal bleeding
• Infertility and pregnancy wastage
• Evaluation of abnormal hysterosalpingogram
• Intrauterine foreign body
• Amenorrhea
• Pelvic pain
Generally recognized indications for operative hysteroscopy include:
• Directed endometrial biopsy
• Polypectomy
• Submucous myomectomy
• Transection of intrauterine adhesions
• Transection of intrauterine septa
• Endometrial ablation
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/K181545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181545: 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/K181545
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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