510(k) · Cleared
ClearedMyosure XL Rod Lens Hysteroscope, Myosure XL Outlfow Channel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · HIH Hysteroscope (And Accessories)
Cleared on Sep 19, 2012 as substantially equivalent to K091465 (Interlace Medical, Inc., 2009) after a 28-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.
- Decided
- Sep 19, 2012
- Review
- 28 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954050 (1995). 9 ancestors in all, the oldest K941541 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK954050 ResectoscopesKARL STORZ Endoscopy-America, Inc. · 1995
- 2 generations backK991563 Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike…Henke Sass Wolf of America, Inc. · 1999
- 1 generation backK091465 Myosure Rod Lens HysteroscopeInterlace Medical, Inc. · 2009
- This deviceK122563 Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow ChannelHologic, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK182006 Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK191281 Omni Hysteroscope, Omni Lok cervical sealHologic, Inc. · 2019
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 |
|---|---|---|---|---|---|
| −3 | K954050 | Resectoscopes | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| −2 | K991563 | Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode… | Henke Sass Wolf of America, Inc. | 1999 | — |
| −1 | K091465 | Myosure Rod Lens Hysteroscope | Interlace Medical, Inc. | 2009 | — |
| 0 (this device) | K122563 | Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow Channel | Hologic, Inc. | 2012 | — |
| +1 | K182006 | Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths | Hologic, Inc. | 2018 | — |
| +2 | K191281 | Omni Hysteroscope, Omni Lok cervical seal | Hologic, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K091465 | Myosure Rod Lens HysteroscopeSummary page 1…accessories Class: 11 Regulation number: 884.1690 Product code: HIB 3. Predicate Device: MyoSure Rod Lens Hysteroscope (K091465) 4. Device Description: The Myosure XL Rod Lens Hysteroscope is comprised of an oval 6.0 mm x 6.4mm G… | 2009 |
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 |
|---|---|---|---|
| K182006 | Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths | 2018 | 1 |
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 17 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K182006 (Hologic, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K091465.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Myosure XL Rod Lens Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122563 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122563: Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow Channel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122563
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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