FDA product code KQS: Table, Cystometric, Non-Electric And Accessories
KQS is the FDA product code for table, cystometric, non-electric and accessories. It is a Class I device, regulated under 21 CFR 876.4890 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 8 510(k) submissions under KQS, from 6 different applicants. The average 510(k) review took 51 days (median 43).
Classification
| Field | Value |
|---|---|
| Device name | Table, Cystometric, Non-Electric And Accessories |
| Device class | Class I |
| Regulation | 21 CFR 876.4890 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KQS clearance
Top KQS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Sterilizer Co. | 2 | 1986-12-24 |
| Mallinckrodt Group, Inc. | 2 | 1986-02-10 |
| Dornier Medtech America, Inc. | 1 | 1995-12-06 |
| Oec-Diasonics, Inc. | 1 | 1987-07-16 |
| Siemens Corp. | 1 | 1980-08-13 |
1 more applicants have KQS clearances. See the full list in Caduvo.
Most recent KQS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K955019 | Dornier Medtech America, Inc. | UROTRACT I | 1995-12-06 | 34 |
| K872022 | Oec-Diasonics, Inc. | UROVIEW | 1987-07-16 | 51 |
| K864846 | American Sterilizer Co. | RADIOGRAPHIC - LEG SECTION | 1986-12-24 | 14 |
| K860040 | Mallinckrodt Group, Inc. | HYDRAJUST III UROLOGICAL TABLE | 1986-02-10 | 35 |
| K852127 | American Sterilizer Co. | AMSCO URO-ENDO MOBILE TABLE | 1985-08-08 | 85 |
Recalls for KQS devices
openFDA lists no recalls for product code KQS.
Frequently asked questions
What is FDA product code KQS?
KQS is the FDA product code for table, cystometric, non-electric and accessories. It is a Class I device, regulated under 21 CFR 876.4890 and reviewed by the Gastroenterology and Urology panel.
What device class is KQS?
Class I, regulation 21 CFR 876.4890. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KQS?
Across 8 cleared submissions the average was 51 days from receipt to decision (median 43).
Which companies have the most KQS clearances?
American Sterilizer Co. (2); Mallinckrodt Group, Inc. (2); Dornier Medtech America, Inc. (1); Oec-Diasonics, Inc. (1); Siemens Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KQS
- Run a recall and safety report across every KQS manufacturer
- Watch product code KQS 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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