510(k) · Cleared
ClearedFemeye Two
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fem Suite, LLC · HIH Hysteroscope (And Accessories)
Cleared on May 18, 2010 as substantially equivalent to K961688 (Imagyn Medical, Inc., 1996) and 1 other predicate after a 217-day review. Its family tree reaches back 9 generations to 1993. 1 of the 32 devices in its family, counting itself, has a Class I recall.
- Decided
- May 18, 2010
- Review
- 217 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K931154 (1993). 31 ancestors in all, the oldest K791182 (1979). No later device cites it as a predicate yet. 1 of the 32 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 5 generations between
- 3 generations backK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- 2 generations backK072594 Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc. · 2007
- 1 generation backK092278 Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc. · 2009
- This deviceK093218 Femeye TwoFem Suite, LLC · 2010
Show all 9 generations
- Root · 9 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 8 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 7 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 6 generations backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- 5 generations backK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- 4 generations backK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
- 3 generations backK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- 2 generations backK072594 Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc. · 2007
- 1 generation backK092278 Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc. · 2009
- This deviceK093218 Femeye TwoFem Suite, LLC · 2010
Class I recalls in this family
- K912120 Urf-P2 Ureterorenofiberscope/Choledochofiberscope6 generations back · 1991
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −8 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −7 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −6 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| −5 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| −4 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
| −3 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| −2 | K072594 | Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope System | Gyrus Acmi, Inc. | 2007 | — |
| −1 | K092278 | Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4 | Gyrus Acmi, Inc. | 2009 | — |
| 0 (this device) | K093218 | Femeye Two | Fem Suite, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1985 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 1 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2003 | 2 | 0 |
| 2005 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K961688 | Microspan HysteroscopeSummary page 2…Comparison to Predicate Device: FernSuite's FemEye Two~ is substantially equivalent in intended use and operation to following predicate devices: K961688 Imagyn Medical Microspan Hysteroscope K092278 Gyrus ACMI Invisio Digital HysteroscopeSystem The… | 1996 |
| * | K092278 | Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Summary page 2…~ is substantially equivalent in intended use and operation to following predicate devices: K961688 Imagyn Medical Microspan Hysteroscope K092278 Gyrus ACMI Invisio Digital HysteroscopeSystem The FemnEye Two is identical to Imagyn Medical Microspan Hysterosc… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 6 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 9 of the 31 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K961688.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 FernEye TWoTm Hysteroseope is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures. Generally recognized indications for diagnostic hysteroscopy include:
* Abnormal Uterine Bleeding
* Infertility and Pregnancy Wastage
* Evaluation of Abnormal Hysterosalpingogramn,
* Intrauterine Foreign Body
* Amenorrhea
* Pelvic Pain
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093218 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093218: Femeye Two.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093218
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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