FDA product code KQO: Automated Urinalysis System
KQO is the FDA product code for automated urinalysis system. It is a Class I device, regulated under 21 CFR 862.2900 and reviewed by the Clinical Chemistry panel. FDA has cleared 46 510(k) submissions under KQO, from 25 different applicants. The average 510(k) review took 143 days (median 98). FDA has posted 33 recalls for KQO devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Automated Urinalysis System |
| Device class | Class I |
| Regulation | 21 CFR 862.2900 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KQO clearance
Top KQO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boehringer Mannheim Corp. | 6 | 1998-10-27 |
| Miles Laboratories, Inc. | 6 | 1984-08-24 |
| Intl. Remote Imaging Systems | 4 | 1997-08-25 |
| ACON Laboratories, Inc. | 2 | 2015-05-11 |
| Arkray, Inc. | 2 | 2013-02-01 |
20 more applicants have KQO clearances. See the full list in Caduvo.
Most recent KQO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K141874 | Yd Diagnostics Corp. | URISCAN OPTIMA | 2015-05-28 | 321 |
| K142543 | ACON Laboratories, Inc. | Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control | 2015-05-11 | 243 |
| K140717 | Siemens Healthcare Diagnostics | CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT | 2014-11-17 | 242 |
| K121456 | Arkray, Inc. | AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL | 2013-02-01 | 261 |
| K102188 | DFI Co., Ltd. | CYBOW READER, MODELS 300 & 720 | 2011-08-09 | 371 |
Recalls for KQO devices
33 product recalls in 22 recall events; 5 initiated in the last five years and 4 still open. Most recent: 2023-04-05.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 4 |
| 2019 | 3 |
| 2020 | 4 |
| 2021 | 1 |
| 2023 | 4 |
Frequently asked questions
What is FDA product code KQO?
KQO is the FDA product code for automated urinalysis system. It is a Class I device, regulated under 21 CFR 862.2900 and reviewed by the Clinical Chemistry panel.
What device class is KQO?
Class I, regulation 21 CFR 862.2900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KQO?
Across 46 cleared submissions the average was 143 days from receipt to decision (median 98).
Which companies have the most KQO clearances?
Boehringer Mannheim Corp. (6); Miles Laboratories, Inc. (6); Intl. Remote Imaging Systems (4); ACON Laboratories, Inc. (2); Arkray, Inc. (2).
Have KQO devices been recalled?
Yes: 33 product recalls across 22 recall events; the most recent began 2023-04-05.
Next steps
- Run an FDA pathway report with predicate devices for product code KQO
- Run a recall and safety report across every KQO manufacturer
- Watch product code KQO 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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