Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Corpak Medsystems — Predicate Candidate Screening

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

76 daysmedian FDA review time
119 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K142012FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ECorpak Medsystems2014-11-201190
K133599CORGRIPCorpak Medsystems2014-03-261210
K131532ELECTROMAGNETIC TRANSMITTING STYLETCorpak Medsystems2013-08-12760
K113351CORTRAK ENTERAL ACCESS DEVICECorpak Medsystems2012-01-10571
K100365FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AICorpak Medsystems2010-05-20970
K091637CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900Corpak Medsystems2009-09-291170
K083776CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-SCorpak Medsystems2009-03-05760
K083791CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-SCorpak Medsystems2009-03-04750
K083786CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006Corpak Medsystems2009-02-20630
K083121NEO MAPCATH SENSOR STYLETCorpak Medsystems2009-02-111120
K083210CORFLO ANTI IV ENTERAL FEEDING TUBECorpak Medsystems2008-12-29590
K990127CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD)Corpak Medsystems1999-02-10280
K840656ENTERNAL Y EXTENSION SET RECORDERCorpak Medsystems1984-04-04490
K831328NEONATAL NASOGASTRIC FEEDING TUBE-Corpak Medsystems1983-07-19850
K821906CORPAK ENTERIC FEEDING TUBE W/GUIDE TIPCorpak Medsystems1982-07-13151

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