Atlas FDA

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

Atrion Medical Products, Inc. · Predicate Candidate Screening

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

90 daysmedian FDA review time
183 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K060643QL LOCKING SYRINGEAtrion Medical Products, Inc.2006-07-121240
K043249ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICEAtrion Medical Products, Inc.2005-05-251830
K041158ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPSAtrion Medical Products, Inc.2004-06-16440
K032840ATRION MEDICAL QL INFLATION DEVICEAtrion Medical Products, Inc.2004-03-031740
K020333ATRION MEDICAL QL FLUID DISPENSING SYRINGEAtrion Medical Products, Inc.2002-04-25840
K973633ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SETAtrion Medical Products, Inc.1998-01-161830
K973872ATRION MEDICAL COATED LACRIMAL INTUBATION SETAtrion Medical Products, Inc.1998-01-08900
K972964ATRION MEDICAL BALLOON CATHETER INFLATION DEVICEAtrion Medical Products, Inc.1997-10-10600
K971100ATRION MEDICAL AUTOGENOUS TISSUE COLLECTORAtrion Medical Products, Inc.1997-05-23580

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