510(k) · Cleared
ClearedTruclear Operative Hysteroscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HIH Hysteroscope (And Accessories)
Cleared on Nov 22, 2011 as substantially equivalent to K013870 (Smith & Nephew, Inc., 2002) after a 118-day review. Its family tree reaches back 2 generations to 1997. 7 later devices descend from it.
- Decided
- Nov 22, 2011
- Review
- 118 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K971188 (1997). 3 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK971188 Smith & Nephew Images Endoscopes and Accessoris/Semi-Rigid and…Smith & Nephew, Inc. · 1997
- 1 generation backK013870 Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew…Smith & Nephew, Inc. · 2002
- This deviceK112134 Truclear Operative HysteroscopeSmith & Nephew, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK152143 TRUCLEAR Operative Hysteroscope 5C and Sheath 5CSmith & Nephew, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK190372 Aveta SystemMeditrina, Inc. · 2019
- Descendant · 3 generations on · 1 of its ownK213171 Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral)…Meditrina, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK223813 Aveta System 2.0Meditrina, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK192100 Aveta Disposable HysteroscopeMeditrina, Inc. · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K152143TRUCLEAR Operative Hysteroscope 5C and Sheath 5CSmith & Nephew, Inc. · 2015 · cites it directly6descendants
- K190372Aveta SystemMeditrina, Inc. · 2019 · 2 generations on4descendants
- K213171Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable…Meditrina, Inc. · 2022 · 3 generations on1descendant
- K223813Aveta System 2.0Meditrina, Inc. · 2023 · 4 generations on0descendants
- K192100Aveta Disposable HysteroscopeMeditrina, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971188 | Smith & Nephew Images Endoscopes and Accessoris/Semi-Rigid and Flexible Manual… | Smith & Nephew, Inc. | 1997 | — |
| −1 | K013870 | Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew… | Smith & Nephew, Inc. | 2002 | — |
| 0 (this device) | K112134 | Truclear Operative Hysteroscope | Smith & Nephew, Inc. | 2011 | — |
| +1 | K152143 | TRUCLEAR Operative Hysteroscope 5C and Sheath 5C | Smith & Nephew, Inc. | 2015 | — |
| +2 | K190372 | Aveta System | Meditrina, Inc. | 2019 | — |
| +3 | K213171 | Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta… | Meditrina, Inc. | 2022 | — |
| +4 | K223813 | Aveta System 2.0 | Meditrina, Inc. | 2023 | — |
| +3 | K192100 | Aveta Disposable Hysteroscope | Meditrina, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K013870 | Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew Continuous Flow…Summary page 1…cation Name: Hysteroscope and Accessories per CER §884.1690 D. Predicate Device The predicate device is the Smith & Nephew Operative Hysteroscope cleared in K013870. E. Description of Device Smith & Nephew's TRUCLEAR Operative Hyteroscope is a rigid hysteroscope that is intended for… | 2002 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152143 | TRUCLEAR Operative Hysteroscope 5C and Sheath 5C | 2015 | 6 |
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 14 years and passes through 1 company; a new generation was cleared every 9.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K152143 (Smith & Nephew, Inc., 2015) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K013870.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Smith & Nephew IRUCLEAR Operative Hysteroscope is used to permit viewing of
the cervical canal and uterine cavity for the purpose of performing diagnostic and
surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112134: Truclear Operative Hysteroscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112134
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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