510(k) · Cleared
ClearedOmni Hysteroscope, Omni Lok cervical seal
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 Aug 29, 2019 as substantially equivalent to K182006 (Hologic, Inc., 2018) after a 108-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Aug 29, 2019
- Review
- 108 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K954050 (1995). 11 ancestors in all, the oldest K941541 (1994). No later device cites it as a predicate yet.
- Root · 5 generations backK954050 ResectoscopesKARL STORZ Endoscopy-America, Inc. · 1995
- 4 generations backK991563 Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike…Henke Sass Wolf of America, Inc. · 1999
- 3 generations backK091465 Myosure Rod Lens HysteroscopeInterlace Medical, Inc. · 2009
- 2 generations backK122563 Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow ChannelHologic, Inc. · 2012
- 1 generation backK182006 Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc. · 2018
- This deviceK191281 Omni Hysteroscope, Omni Lok cervical sealHologic, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954050 | Resectoscopes | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| −4 | K991563 | Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode… | Henke Sass Wolf of America, Inc. | 1999 | — |
| −3 | K091465 | Myosure Rod Lens Hysteroscope | Interlace Medical, Inc. | 2009 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K182006 | Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsSummary page 4…assification: Class I, exempt Panel: Obstetrics/Gynecology PREDICATE DEVICE Tradename: Omni hysteroscope Submitter/510(k) Holder: Hologic, Inc. 510(k) #: K182006 Product Code: HIH Regulation: 21 CFR 884.1690 The Omni hysteroscope has not been subject to a design-related recall.… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 11 ancestors has a recall.
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?
Omni hysteroscope:
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.
Omni Lok cervical seal:
The Omni Lok cervical seal is used during a hysteroscopic procedure to minimize liquid distention media leakage from the cervix.
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/K191281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191281: Omni Hysteroscope, Omni Lok cervical seal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191281
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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