510(k) · Cleared
ClearedFemrx Operastar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gynecare Innovation Center · HIH Hysteroscope (And Accessories)
Cleared on Mar 14, 1996 after a 156-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.
- Decided
- Mar 14, 1996
- Review
- 156 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK954648 Femrx Operastar SystemGynecare Innovation Center · 1996
- Descendant · cites it directly · 0 of its ownK131656 Morcellex Sigma GeneratorETHICON, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K131656Morcellex Sigma GeneratorETHICON, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954648 | Femrx Operastar System | Gynecare Innovation Center | 1996 | — |
| +1 | K131656 | Morcellex Sigma Generator | ETHICON, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 |
|---|---|---|---|
| K131656 | Morcellex Sigma Generator | 2013 | 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?
- Of its descendants, K131656 (ETHICON, Inc., 2013) 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.
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 | — |
https://510kreport.com/device/K954648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954648: Femrx Operastar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954648
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026