Atlas FDA

KMG

9 FDA 510(k) clearances · Product code

35 daysmedian time to decision
186 days90th percentile
9clearances measured

FDA profile

Official device name
Purifier, Water, Ultraviolet, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6710
Medical specialty
General Hospital
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RecordFirmDate
REMEDY MODEL 2Z12 (K012029)Apollo Corp.2001-12-31
HEMOGLOBINOMETER (K832288)Mallinckrodt Critical Care1983-09-01
LANCER HEMOGLOBIN ANALYZER REAGENTS (K831253)Sherwood Medical Co.1983-05-09
AQUANOMICS, #HHU100 (K813049)Cooper-Hewitt Electric Co.1981-12-02
AQUANOMICS, #SP36SF (K813045)Cooper-Hewitt Electric Co.1981-12-02
AQUANOMICS, #MP2SF (K813048)Cooper-Hewitt Electric Co.1981-12-02
AQUANOMICS, #MP4SF (K813050)Cooper-Hewitt Electric Co.1981-12-02
AQUANOMICS, MINI 60L (K813047)Cooper-Hewitt Electric Co.1981-12-02
AQUANOMICS, #HHU60 (K813046)Cooper-Hewitt Electric Co.1981-12-02

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Every clearance here is in the API, with alerts when new ones post.