510(k) · Cleared
ClearedCT3000Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Srs Medical · FEN Device, Cystometric, Hydraulic
Cleared on Dec 21, 2021 as substantially equivalent to K073552 (Laborie Medical Technologies, Corp., 2008) after a 105-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Dec 21, 2021
- Review
- 105 days
- Class
- Class II
- Product code
- FEN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K931574 (1993). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K073552 | Laborie Urodynamic System with Tetra AccessorySummary page 4…Class II Panel: Gastroenterology/Urology 3. Predicate Device: Laborie Urodynamics System with Tetra, Product Code FEN, EXQ; cleared under K073552. The predicate device has not been subjected to a design-related recall. 4. Device Description: The CT3000Pro system is an ur… | 2008 |
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 28 years and passes through 3 companies; a new generation was cleared every 14.6 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K073552.
How does its category compare?
All FEN devicesFEN Device, Cystometric, Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
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 CT3000Pro is intended for urodynamic testing. The equipment performs standard tests including uroflowmeter,
cystometry, micturition, electromyography and urethral pressure profiles. The non-invasive option utilizes a penile cuff
(UroCuff-Classic or UroCuff-DC) for non-invasive testing of bladder activity, by assessing the pressure necessary to
interrupt urine flow.
The CT3000Pro is intended for use under the direction of a licensed physician or health care professional in an office or
hospital setting.
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/K212830 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212830: CT3000Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212830
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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