FDA product code EXQ: Cystometer, Electrical Recording
EXQ is the FDA product code for cystometer, electrical recording. It is a Class II device, regulated under 21 CFR 876.1620 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 8 510(k) submissions under EXQ, 2 in the last five years, from 7 different applicants. The average 510(k) review took 166 days (median 166); 166 days on average over the last three years. FDA has posted 1 recall for EXQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Cystometer, Electrical Recording |
| Device class | Class II |
| Regulation | 21 CFR 876.1620 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for EXQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 178 |
| 2026 | 1 | 154 |
Compare with all 510(k) review times · Search every EXQ clearance
Top EXQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bright Uro, Inc. | 2 | 2026-04-16 |
| Life-Tech Intl., Inc. | 1 | 1993-09-17 |
| Laborie Medical Technologies, Ltd. | 1 | 1993-08-05 |
| F.M. Wiest USA, Inc. | 1 | 1993-02-17 |
| Dacomed Corp. | 1 | 1988-04-27 |
2 more applicants have EXQ clearances. See the full list in Caduvo.
Most recent EXQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253537 | Bright Uro, Inc. | 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) | 2026-04-16 | 154 |
| K243052 | Bright Uro, Inc. | 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)) | 2025-03-24 | 178 |
| K931282 | Life-Tech Intl., Inc. | VOLUME TRANSDUCER | 1993-09-17 | 189 |
| K931574 | Laborie Medical Technologies, Ltd. | ADVANCE MODEL UDS-ADV | 1993-08-05 | 128 |
| K920574 | F.M. Wiest USA, Inc. | CAMSYS 6300 | 1993-02-17 | 376 |
Recalls for EXQ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-04-09.
Frequently asked questions
What is FDA product code EXQ?
EXQ is the FDA product code for cystometer, electrical recording. It is a Class II device, regulated under 21 CFR 876.1620 and reviewed by the Gastroenterology and Urology panel.
What device class is EXQ?
Class II, regulation 21 CFR 876.1620. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EXQ?
Across 8 cleared submissions the average was 166 days from receipt to decision (median 166).
Which companies have the most EXQ clearances?
Bright Uro, Inc. (2); Life-Tech Intl., Inc. (1); Laborie Medical Technologies, Ltd. (1); F.M. Wiest USA, Inc. (1); Dacomed Corp. (1).
Have EXQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2009-04-09.
Next steps
- Run an FDA pathway report with predicate devices for product code EXQ
- Run a recall and safety report across every EXQ manufacturer
- Watch product code EXQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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