510(k) · Cleared
ClearedFemiscan Clinic System, Model FS-Ictra and Femiscan Personal System, Model FS-HMTR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mega Electronics, Ltd. · HIR Perineometer
Cleared on Jan 10, 2000 as substantially equivalent to K974048 (Hollister, Inc., 1997) and 4 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Jan 10, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K930530 (1995). 5 ancestors in all, the oldest K891774 (1989). No later device cites it as a predicate yet.
- Root · 3 generations backK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
- 2 generations backK961872 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1996
- 1 generation backK974048 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1997
- This deviceK993411 Femiscan Clinic System, Model FS-Ictra and Femiscan Personal System…Mega Electronics, Ltd. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc | Hollister, Inc. | 1995 | — |
| −2 | K961872 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1996 | — |
| −1 | K974048 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1997 | — |
| 0 (this device) | K993411 | Femiscan Clinic System, Model FS-Ictra and Femiscan Personal System, Model… | Mega Electronics, Ltd. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 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 HIR? 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 HIR device
- #1 K252748 Pelvic Floor Exerciser (PF01)score 12.4 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K974048 | Incare Pelvic Floor Therapy System with Desktop ComputerSummary page 1…™ Clinic System is substantially equivalent to the following Hollister Incorporated predicate devices: InCare Pelvic Floor Therapy System with Desktop Computer PRS 9300 (K974048, K961872 and K930530) and the InCare Contimed Biofeedback devices for treatment of urinary incontinence (K960311 and K891774). 4… | 1997 |
| * | K961872 | Incare Pelvic Floor Therapy System with Desktop ComputerSummary page 1…System is substantially equivalent to the following Hollister Incorporated predicate devices: InCare Pelvic Floor Therapy System with Desktop Computer PRS 9300 (K974048, K961872 and K930530) and the InCare Contimed Biofeedback devices for treatment of urinary incontinence (K960311 and K891774). 4. The Fem… | 1996 |
| * | K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncSummary page 1…bstantially equivalent to the following Hollister Incorporated predicate devices: InCare Pelvic Floor Therapy System with Desktop Computer PRS 9300 (K974048, K961872 and K930530) and the InCare Contimed Biofeedback devices for treatment of urinary incontinence (K960311 and K891774). 4. The FemiScan™ Clini… | 1995 |
| * | K960311 | PerineometerSummary page 1…vic Floor Therapy System with Desktop Computer PRS 9300 (K974048, K961872 and K930530) and the InCare Contimed Biofeedback devices for treatment of urinary incontinence (K960311 and K891774). 4. The FemiScan™ Clinic and Personal Systems consist of a palm- sized measuring unit with a computer-based user in… | 1996 |
| * | K891774 | Contimed II Biofeedback Dev Treat of Urin IncontiSummary page 1…erapy System with Desktop Computer PRS 9300 (K974048, K961872 and K930530) and the InCare Contimed Biofeedback devices for treatment of urinary incontinence (K960311 and K891774). 4. The FemiScan™ Clinic and Personal Systems consist of a palm- sized measuring unit with a computer-based user interface and… | 1989 |
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 5 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 5 ancestors has a recall.
- 4 other devices also cite its predicate K974048.
How does its category compare?
All HIR devicesHIR Perineometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIR
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HIR
187in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIR
No recall names HIR since 2007.
Adverse event reports per year · HIR
1in 2024
MAUDE reports naming product code HIR, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 166 | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 3 | 29 | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 3 | 187 | 0 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Indications: The FemiScan™ devices are intended as an aid for exercising and training pelvic floor muscle activation, control and optionally coordination with the abdominal muscle group. It is indicated in the treatment of stress and mixed female urinary incontinence under the supervision of a physician. The FemiScan™ Clinic System is used in the physician office, clinic, or hospital environment. The FemiScan™ Personal System is used to supplement these exercises in the home environment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993411 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993411: Femiscan Clinic System, Model FS-Ictra and Femiscan Personal System, Model FS-HMTR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993411
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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