Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Artec Environmental Monitoring Division · Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

55 daysmedian FDA review time
174 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K900839THE CAROLINA ROCKERArtec Environmental Monitoring Division1990-04-18550
K896886ARTEC RESPOND PULMONARY RESUSCITATORArtec Environmental Monitoring Division1990-02-06600
K873043MOUTH TO FACE RESUSCITATORArtec Environmental Monitoring Division1987-09-28550
K863910RAINCOATArtec Environmental Monitoring Division1986-10-20120
K854573ANESTHESIA SHUTOFF VALVE POSITIVE CLOSUREArtec Environmental Monitoring Division1986-01-03500
K832512AIRWAY MASKSArtec Environmental Monitoring Division1984-01-171740
K830056ARTEC TWIST VALVEArtec Environmental Monitoring Division1983-03-09620

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda