510(k) · Cleared
ClearedGlean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bright Uro, Inc. · EXQ Cystometer, Electrical Recording
Cleared on Apr 16, 2026 as substantially equivalent to K243052 (Bright Uro, Inc., 2025) after a 154-day review. Its family tree reaches back 1 generation to 2025.
- Decided
- Apr 16, 2026
- Review
- 154 days
- Class
- Class II
- Product code
- EXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K243052 (2025). No later device cites it as a predicate yet.
- Root · 1 generation backK243052 Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean…Bright Uro, Inc. · 2025
- This deviceK253537 Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean…Bright Uro, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K243052 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics… | Bright Uro, Inc. | 2025 | — |
| 0 (this device) | K253537 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics… | Bright Uro, Inc. | 2026 | — |
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 EXQ? 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? (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 |
|---|---|---|---|
| * | K243052 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System…Summary page 5…logy/Urology Product Code: EXQ, EXY 3. Predicate Devices 510(k)# Trade Name Primary Predicate K243052 Glean Urodynamics System Secondary Predicate 510(k) Exempt Laborie Goby System The predicate devices… | 2025 |
| * | — | Laborie Goby System 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 EXQ devicesEXQ Cystometer, Electrical Recording: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · EXQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EXQ
Too few EXQ 510(k)s in any year since 2007 to give a median.
Recalls per year · EXQ
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EXQ
1in 2024
MAUDE reports naming product code EXQ, 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 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Glean Urodynamics System is a urodynamics analyzer system that is intended to quantify the pressure and flow characteristics of the lower-urinary tract. The system can be used in adult patients only to perform standard urodynamic tests such as Uroflow, Cystometrogram (CMG), Urethral Pressure Profile (UPP) and Micturition Studies.
The major application of urodynamics is the diagnosis of uncontrolled loss of urine (incontinence), abnormal urinary retention, or neurological cases of micturition disorder. The system is intended to be used as medical diagnostic equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253537 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253537: Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253537
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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