510(k) · Cleared
ClearedIN-Probe II Urodynamic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Influence, Inc. · FEN Device, Cystometric, Hydraulic
Cleared on Nov 24, 1998 as substantially equivalent to K940812 (Andronic Devices, Ltd., 1994) after a 63-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Nov 24, 1998
- Review
- 63 days
- Class
- Class II
- Product code
- FEN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940812 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK940812 Insight Electronic Alignment IndicatorAndronic Devices, Ltd. · 1994
- This deviceK983325 IN-Probe II Urodynamic SystemInfluence, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940812 | Insight Electronic Alignment Indicator | Andronic Devices, Ltd. | 1994 | — |
| 0 (this device) | K983325 | IN-Probe II Urodynamic System | Influence, Inc. | 1998 | — |
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 FEN? 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 FEN device
- #1 K212830 CT3000Proscore 2.9 · 2 generations · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K940812 | Insight Electronic Alignment IndicatorSummary page 1…Urodynamics System has an angle sensor that is substantially equivalent technologically to Andronic Devices, Ltd.’s Insight electronic alignment indicator cleared under K940812, and to the preamendments Q-tip test in terms of intended use. Indication for Use: The In-Probe II Urodynamic System is indicat… | 1994 |
| * | — | In-Probe Urodynamics System Named without a submission number | |
| * | — | pre-amendments Q-tip test Named without a submission number |
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?
- Its one ancestor has no recall.
How does its category compare?
All FEN devicesFEN Device, Cystometric, Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FEN
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · FEN
Too few FEN 510(k)s in any year since 2007 to give a median.
Recalls per year · FEN
No recall names FEN since 2007.
Adverse event reports per year · FEN
3in 2024
MAUDE reports naming product code FEN, 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 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 33 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The In-Probe II Urodynamic System is indicated as an aid in the diagnosis of voiding dysfunction in males and females. In females, the In-Probe II Urodynamic System is also indicated for measuring urethral angle during straining.
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/K983325 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983325: IN-Probe II Urodynamic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983325
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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