510(k) · Cleared
ClearedTruClear Elite Hysteroscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · HIH Hysteroscope (And Accessories)
Cleared on Aug 29, 2018 as substantially equivalent to K013870 (Smith & Nephew, Inc., 2002) and 1 other predicate after a 184-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Aug 29, 2018
- Review
- 184 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K971188 (1997). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK971188 Smith & Nephew Images Endoscopes and Accessoris/Semi-Rigid and…Smith & Nephew, Inc. · 1997
- 3 generations backK013870 Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew…Smith & Nephew, Inc. · 2002
- 2 generations backK112134 Truclear Operative HysteroscopeSmith & Nephew, Inc. · 2011
- 1 generation backK152143 TRUCLEAR Operative Hysteroscope 5C and Sheath 5CSmith & Nephew, Inc. · 2015
- This deviceK180496 TruClear Elite HysteroscopeCovidien · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971188 | Smith & Nephew Images Endoscopes and Accessoris/Semi-Rigid and Flexible Manual… | Smith & Nephew, Inc. | 1997 | — |
| −3 | K013870 | Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew… | Smith & Nephew, Inc. | 2002 | — |
| −2 | K112134 | Truclear Operative Hysteroscope | Smith & Nephew, Inc. | 2011 | — |
| −1 | K152143 | TRUCLEAR Operative Hysteroscope 5C and Sheath 5C | Smith & Nephew, Inc. | 2015 | — |
| 0 (this device) | K180496 | TruClear Elite Hysteroscope | Covidien | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K013870 | Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew Continuous Flow…Summary page 4…ysteroscope 5C Common Name: Hysteroscope Classification Name: Hysteroscope & Accessories, HIH, 21 CFR 884.1690 510(k) Number: K013870, K152143 Manufacturer: Smith & Nephew, 150 Minuteman Drive, Andover, MA The predicate devices have not been sub… | 2002 |
| * | K152143 | TRUCLEAR Operative Hysteroscope 5C and Sheath 5CSummary page 4…pe 5C Common Name: Hysteroscope Classification Name: Hysteroscope & Accessories, HIH, 21 CFR 884.1690 510(k) Number: K013870, K152143 Manufacturer: Smith & Nephew, 150 Minuteman Drive, Andover, MA The predicate devices have not been subject to a… | 2015 |
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 21 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- None of the 5 ancestors has a recall.
- 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. 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 TruClear Elite Hysteroscope is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180496: TruClear Elite Hysteroscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180496
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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