FDA product code KMG: Purifier, Water, Ultraviolet, Medical
KMG is the FDA product code for purifier, water, ultraviolet, medical. It is a Class II device, regulated under 21 CFR 880.6710 and reviewed by the General Hospital panel. FDA has cleared 9 510(k) submissions under KMG, from 4 different applicants. The average 510(k) review took 52 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Purifier, Water, Ultraviolet, Medical |
| Device class | Class II |
| Regulation | 21 CFR 880.6710 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Top KMG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cooper-Hewitt Electric Co. | 6 | 1981-12-02 |
| Apollo Corp. | 1 | 2001-12-31 |
| Mallinckrodt Critical Care | 1 | 1983-09-01 |
| Sherwood Medical Co. | 1 | 1983-05-09 |
Most recent KMG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K012029 | Apollo Corp. | REMEDY MODEL 2Z12 | 2001-12-31 | 186 |
| K832288 | Mallinckrodt Critical Care | HEMOGLOBINOMETER | 1983-09-01 | 50 |
| K831253 | Sherwood Medical Co. | LANCER HEMOGLOBIN ANALYZER REAGENTS | 1983-05-09 | 21 |
| K813046 | Cooper-Hewitt Electric Co. | AQUANOMICS, #HHU60 | 1981-12-02 | 35 |
| K813048 | Cooper-Hewitt Electric Co. | AQUANOMICS, #MP2SF | 1981-12-02 | 35 |
Recalls for KMG devices
openFDA lists no recalls for product code KMG.
Frequently asked questions
What is FDA product code KMG?
KMG is the FDA product code for purifier, water, ultraviolet, medical. It is a Class II device, regulated under 21 CFR 880.6710 and reviewed by the General Hospital panel.
What device class is KMG?
Class II, regulation 21 CFR 880.6710. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KMG?
Across 9 cleared submissions the average was 52 days from receipt to decision (median 35).
Which companies have the most KMG clearances?
Cooper-Hewitt Electric Co. (6); Apollo Corp. (1); Mallinckrodt Critical Care (1); Sherwood Medical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KMG
- Run a recall and safety report across every KMG manufacturer
- Watch product code KMG 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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