510(k) · Cleared
ClearedOmni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
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 Dec 6, 2018 as substantially equivalent to K122563 (Hologic, Inc., 2012) and 1 other predicate after a 132-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Dec 6, 2018
- Review
- 132 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K954050 (1995). 10 ancestors in all, the oldest K941541 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK954050 ResectoscopesKARL STORZ Endoscopy-America, Inc. · 1995
- 3 generations backK991563 Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike…Henke Sass Wolf of America, Inc. · 1999
- 2 generations backK091465 Myosure Rod Lens HysteroscopeInterlace Medical, Inc. · 2009
- 1 generation backK122563 Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow ChannelHologic, Inc. · 2012
- This deviceK182006 Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK191281 Omni Hysteroscope, Omni Lok cervical sealHologic, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K191281Omni Hysteroscope, Omni Lok cervical sealHologic, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954050 | Resectoscopes | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| −3 | K991563 | Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode… | Henke Sass Wolf of America, Inc. | 1999 | — |
| −2 | K091465 | Myosure Rod Lens Hysteroscope | Interlace Medical, Inc. | 2009 | — |
| −1 | K122563 | Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow Channel | Hologic, Inc. | 2012 | — |
| 0 (this device) | K182006 | Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths | Hologic, Inc. | 2018 | — |
| +1 | 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 |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K122563 | Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow ChannelSummary page 4…on: Class II Panel: Obstetrics/Gynecology PREDICATE DEVICES Tradename: MyoSure XL Rod Lens Hysteroscope Submitter/510(k) Holder: Hologic, Inc. 510(k) #: K122563 Product Code: HIH Regulation: 21CFR 884.1690 Tradename: MyoSure Rod Lens Hysteroscope Submitter/510(k)… | 2012 |
| * | K091465 | Myosure Rod Lens HysteroscopeSummary page 4…Product Code: HIH Regulation: 21CFR 884.1690 Tradename: MyoSure Rod Lens Hysteroscope Submitter/510(k) Holder: Hologic, Inc. 510(k) #: K091465 Product Code: HIH Regulation: 21CFR 884.1690 The MyoSure and MyoSure XL Rod Lens Hysteroscopes have not been subj… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191281 | Omni Hysteroscope, Omni Lok cervical seal | 2019 | 0 |
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 23 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K191281 (Hologic, Inc., 2019) 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. 2018, 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 Omni 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/K182006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182006: Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182006
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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