510(k) · Cleared
ClearedInterlace Medical Operative Hysteroscopy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interlace Medical, Inc. · HIH Hysteroscope (And Accessories)
Cleared on Jul 23, 2008 as substantially equivalent to K013870 (Smith & Nephew, Inc., 2002) after a 99-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Jul 23, 2008
- Review
- 99 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. No later device cites it as a predicate yet.
- 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 deviceK081070 Interlace Medical Operative Hysteroscopy SystemInterlace Medical, Inc. · 2008
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) | K081070 | Interlace Medical Operative Hysteroscopy System | Interlace Medical, Inc. | 2008 | — |
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? (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…d Device The Interlace Medical Operative Hysteroscopy System is substantially equivalent to the Smith and Nephew Hysteroscope and Accessories cleared under K013870 4. Device Description The Interlace Medical Operative Hysteroscopy System is intended for use in visualizing t… | 2002 |
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 11 years and passes through 2 companies; a new generation was cleared every 6.5 years on median.
- None of the 3 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. 2008, 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?
Interlace Medical Operative Hysteroscopy System 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/K081070 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081070: Interlace Medical Operative Hysteroscopy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081070
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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