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))
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 Mar 24, 2025 after a 178-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Mar 24, 2025
- Review
- 178 days
- Class
- Class II
- Product code
- EXQ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK243052 Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean…Bright Uro, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK253537 Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean…Bright Uro, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253537Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System…Bright Uro, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K243052 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics… | Bright Uro, Inc. | 2025 | — |
| +1 | K253537 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics… | Bright Uro, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 EXQ? 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 EXQ device
- #1 K253537 Glean Urodynamics System Male Delivery System…score 11.2 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | — | Laborie Goby System Named without a submission number | |
| † | K960503 | Dantec Duet | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253537 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System… | 2026 | 0 |
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, K253537 (Bright Uro, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EXQ devicesEXQ Cystometer, Electrical Recording: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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/K243052 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243052: 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)).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243052
Report an extraction error
Are you the manufacturer?
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