510(k) Report

510(k) · Cleared

Cleared

Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc

K930530510(k) TraditionalCleared Oct 17, 1995987-day reviewClass II21 CFR 876.5320

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hollister, Inc. · KPI Stimulator, Electrical, Non-Implantable, For Incontinence

Cleared on Oct 17, 1995 after a 987-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 67 later devices descend from it.

Decided
Oct 17, 1995
Review
987 days
Class
Class II
Product code
KPI
Recalls
None
Predicates
0

67 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared1996: 2 descendants cleared2000: 2 descendants cleared1999: 1 descendant cleared1997: 2 descendants cleared2005: 1 descendant cleared1998: 1 descendant cleared2003: 4 descendants cleared2001: 1 descendant cleared2016: 3 descendants cleared2013: 1 descendant cleared2014: 3 descendants cleared2012: 1 descendant cleared2006: 1 descendant cleared2022: 4 descendants cleared2015: 6 descendants cleared2021: 3 descendants cleared2024: 3 descendants cleared2008: 1 descendant cleared2009: 1 descendant cleared2020: 4 descendants cleared2018: 2 descendants cleared2019: 2 descendants cleared2025: 6 descendants cleared2023: 4 descendants cleared2026: 6 descendants cleared2017: 1 descendant cleared1995200020052010201520202025
  1. This deviceK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
  2. Descendant · cites it directly · 46 of its ownK961872 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1996
  3. Descendant · 2 generations on · 42 of its ownK974048 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1997
  4. Descendant · 3 generations on · 39 of its ownK023906 Pathway CTS2000 Pelvic Floor Training SystemThe Prometheus Group · 2003
  5. Descendant · cites it directly · 38 of its ownK013612 Incare Pelvic Floor Therapy SystemHollister, Inc. · 2002
  6. Descendant · 2 generations on · 37 of its ownK050483 Evadri Bladder Control SystemsHollister, Inc. · 2005

Showing 5 of 67 descendants. See all descendants

Descendants cleared per year

1996: 21997: 21998: 11999: 12000: 22001: 12002: 12003: 42005: 12006: 12008: 12009: 12012: 12013: 12014: 32015: 62016: 32017: 12018: 22019: 22020: 42021: 32022: 42023: 42024: 32025: 62026: 6
1996high 6 (2015) · low 0 (2004)2026

Most influential descendants

Showing 5 of 67 · See all
  • K961872Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1996 · cites it directly46descendants
  • K974048Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1997 · 2 generations on42descendants
  • K023906Pathway CTS2000 Pelvic Floor Training SystemThe Prometheus Group · 2003 · 3 generations on39descendants
  • K013612Incare Pelvic Floor Therapy SystemHollister, Inc. · 2002 · cites it directly38descendants
  • K050483Evadri Bladder Control SystemsHollister, Inc. · 2005 · 2 generations on37descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930530Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc.1995—
+1K961872Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc.1996—
+2K974048Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc.1997—
+3K023906Pathway CTS2000 Pelvic Floor Training SystemThe Prometheus Group2003—
+1K013612Incare Pelvic Floor Therapy SystemHollister, Inc.2002—
+2K050483Evadri Bladder Control SystemsHollister, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199720
199810
199910
200020
200110
200210
200340
200510
200610
200810
200910
201210
201310
201430
201560
201630
201710
201820
201920
202040
202130
202240
202340
202430
202560
202660
FIG. 1 — Lineage of K930530, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 KPI? 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 KPI device

  1. #1 K262353 BTL-299-Fscore 14.8 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (67)

See all 67

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K961872Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc.199646
K013612Incare Pelvic Floor Therapy SystemHollister, Inc.200238
K963222Microgyn Plus Stimulation DeviceHollister, Inc.199626
K990456Anal 2 Electrode Stimulation/Emg Probe - W/StopHollister, Inc.19996
K971541Vaginal 2 Electrode Stimulation/Emg Probe - TamponHollister, Inc.19976
K993976Pathway Vaginal Emg/Stim Perineometer Sensor, Pathway Anal Emg/Stim Perineometer SensorThe Prometheus Group20000
K993411Femiscan Clinic System, Model FS-Ictra and Femiscan Personal System, Model FS-HMTRMega Electronics, Ltd.20000

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, K961872 (Hollister, Inc., 1996) has gone furthest, with 46 descendants of its own.

How does its category compare?

All KPI devices

KPI Stimulator, Electrical, Non-Implantable, For Incontinence: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KPI

7so far in 2026, the most since 2007

2007: 12008: 12009: 22011: 12012: 22013: 12014: 32015: 62016: 32017: 12018: 32019: 22020: 12021: 32022: 32023: 32024: 42025: 42026 (partial year): 7
2007high 7 (2026) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPI

263in 2025

2014: 57 days median2015: 260 days median2016: 89 days median2018: 304 days median2021: 217 days median2022: 181 days median2023: 197 days median2024: 172 days median2025: 263 days median2026 (partial year): 248 days median
2007high 304 (2018) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KPI

No recall names KPI since 2007.

Adverse event reports per year · KPI

2in 2024

2013: 12015: 22017: 42019: 22020: 32021: 12022: 22023: 62024: 2
2007high 6 (2023) · low 0 (2007)2025

MAUDE reports naming product code KPI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20081—00
20092—00
20100—00
20111—00
20122—00
20131—01
201435700
2015626002
201638900
20171—04
2018330400
20192—02
20201—03
2021321701
2022318102
2023319706
2024417202
2025426300
202672480—

More from Hollister, Inc.

85 FDA decisions under this applicant name. See the company

  • K123804Instaflo Bowel Catheter System KitHollister, Inc. · 2013
  • K100273Instaflo Bowel Catheter System KitHollister, Inc. · 2010
  • K090960Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144…Hollister, Inc. · 2009
  • K083153Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007Hollister, Inc. · 2009
  • K050483Evadri Bladder Control SystemsHollister, Inc. · 2005

Recent decisions in KPI

The KPI category page

  • K262353BTL-299-FBTL Industries, Inc. · 2026
  • K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd. · 2026
  • K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle…Hunan Accurate Bio-Medical Technology Co., Ltd. · 2026
  • K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd. · 2026
  • K252831Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)Dolanvy (Suzhou) Medical Technology Co., Ltd. · 2026

https://510kreport.com/device/K930530 · printed Nov 6, 2026

Cite this page

510(k) Report. “K930530: Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930530

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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