FDA product code KHO: Fluorometer, For Clinical Use
KHO is the FDA product code for fluorometer, for clinical use. It is a Class I device, regulated under 21 CFR 862.2560 and reviewed by the Clinical Chemistry panel. FDA has cleared 38 510(k) submissions under KHO, from 28 different applicants. The average 510(k) review took 71 days (median 42). FDA has posted 32 recalls for KHO devices.
Classification
| Field | Value |
|---|---|
| Device name | Fluorometer, For Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2560 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KHO clearance
Top KHO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Perkin-Elmer Corp. | 5 | 1987-07-01 |
| Pb Diagnostic Systems, Inc. | 2 | 1993-06-07 |
| Tosoh Corp. | 2 | 1992-07-21 |
| Baxter Healthcare Corp | 2 | 1991-09-27 |
| Lkb Instruments, Inc. | 2 | 1985-05-24 |
23 more applicants have KHO clearances. See the full list in Caduvo.
Most recent KHO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K112161 | Radiometer Medical Aps | AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE.. | 2012-01-20 | 177 |
| K973547 | Biosite Incorporated | TRIAGE STATMETER | 1998-01-13 | 117 |
| K971103 | Tosoh Medics, Inc. | AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM | 1997-06-27 | 93 |
| K962919 | Johnson & Johnson Clinical Diagnostics, Inc. | VITROS IMMUNODIAGNOSTIC SYSTEM | 1996-10-18 | 84 |
| K952719 | Biocircuits Corp. | BIOCIRCUITS IOS (IN-OFFICE SYSTEM) | 1995-11-22 | 160 |
Recalls for KHO devices
32 product recalls in 20 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-05-22.
| Year | Recalls |
|---|---|
| 2017 | 6 |
| 2018 | 7 |
| 2019 | 2 |
| 2020 | 2 |
Frequently asked questions
What is FDA product code KHO?
KHO is the FDA product code for fluorometer, for clinical use. It is a Class I device, regulated under 21 CFR 862.2560 and reviewed by the Clinical Chemistry panel.
What device class is KHO?
Class I, regulation 21 CFR 862.2560. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KHO?
Across 38 cleared submissions the average was 71 days from receipt to decision (median 42).
Which companies have the most KHO clearances?
The Perkin-Elmer Corp. (5); Pb Diagnostic Systems, Inc. (2); Tosoh Corp. (2); Baxter Healthcare Corp (2); Lkb Instruments, Inc. (2).
Have KHO devices been recalled?
Yes: 32 product recalls across 20 recall events; the most recent began 2020-05-22.
Next steps
- Run an FDA pathway report with predicate devices for product code KHO
- Run a recall and safety report across every KHO manufacturer
- Watch product code KHO 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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