EXQ
8 FDA 510(k) clearances · Product code
178 daysmedian time to decision
376 days90th percentile
8clearances measured
FDA profile
- Official device name
- Cystometer, Electrical Recording
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1620
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2010: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| 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) (K253537) | Bright Uro, Inc. | 2026-04-16 |
| 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)) (K243052) | Bright Uro, Inc. | 2025-03-24 |
| VOLUME TRANSDUCER (K931282) | Life-Tech Intl., Inc. | 1993-09-17 |
| ADVANCE MODEL UDS-ADV (K931574) | Laborie Medical Technologies, Ltd. | 1993-08-05 |
| CAMSYS 6300 (K920574) | F.M. Wiest USA, Inc. | 1993-02-17 |
| DACOMED CYSTOMETER (K880391) | Dacomed Corp. | 1988-04-27 |
| LIFE-TECH #1857 PRESSURE/POLOT MODULE (K812177) | Life-Tech Instruments, Inc. | 1981-09-09 |
| AQUA-GEL (K781032) | Murray, Salk, Inc. | 1978-12-15 |
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Every clearance here is in the API, with alerts when new ones post.