FDA product code KQT: Evacuator, Gastro-Urology
KQT is the FDA product code for evacuator, gastro-urology. It is a Class II device, regulated under 21 CFR 876.4370 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 14 510(k) submissions under KQT, from 12 different applicants. The average 510(k) review took 72 days (median 45). FDA has posted 12 recalls for KQT devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Evacuator, Gastro-Urology |
| Device class | Class II |
| Regulation | 21 CFR 876.4370 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KQT clearance
Top KQT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Northgate Technologies, Inc. | 2 | 1992-10-28 |
| The Healthcare Group Laboratories, Inc. | 2 | 1980-08-13 |
| Electro Medical Systems SA | 1 | 1996-12-16 |
| Mitron Technologies, Inc. | 1 | 1991-04-01 |
| Van-Tec, Inc. | 1 | 1988-03-02 |
7 more applicants have KQT clearances. See the full list in Caduvo.
Most recent KQT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K964111 | Electro Medical Systems SA | LITHOVAC SUCTION/ASPIRATION PROBE | 1996-12-16 | 62 |
| K921088 | Northgate Technologies, Inc. | EVACUATOR, GASTRO-UROLOGY | 1992-10-28 | 236 |
| K921451 | Northgate Technologies, Inc. | EVACUATOR, GASTRO-UROLOGY | 1992-10-28 | 216 |
| K910728 | Mitron Technologies, Inc. | CLEANFLOW SYSTEM | 1991-04-01 | 40 |
| K880099 | Van-Tec, Inc. | VAN-TEC BLADDER EVACUATOR | 1988-03-02 | 50 |
Recalls for KQT devices
12 product recalls in 4 recall events; 10 initiated in the last five years and 10 still open. Most recent: 2026-05-05.
| Year | Recalls |
|---|---|
| 2025 | 6 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code KQT?
KQT is the FDA product code for evacuator, gastro-urology. It is a Class II device, regulated under 21 CFR 876.4370 and reviewed by the Gastroenterology and Urology panel.
What device class is KQT?
Class II, regulation 21 CFR 876.4370. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KQT?
Across 14 cleared submissions the average was 72 days from receipt to decision (median 45).
Which companies have the most KQT clearances?
Northgate Technologies, Inc. (2); The Healthcare Group Laboratories, Inc. (2); Electro Medical Systems SA (1); Mitron Technologies, Inc. (1); Van-Tec, Inc. (1).
Have KQT devices been recalled?
Yes: 12 product recalls across 4 recall events; the most recent began 2026-05-05.
Next steps
- Run an FDA pathway report with predicate devices for product code KQT
- Run a recall and safety report across every KQT manufacturer
- Watch product code KQT 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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