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

Amedic USA — Predicate Candidate Screening

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

129 daysmedian FDA review time

158 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K897120	EQUIP COVERS, STERILE	Amedic USA	1990-01-04	9
K892070	GENERAL IVT NEEDLE GUIDE KIT, STERILE	Amedic USA	1989-09-05	158
K892069	EXTENDED COVERS, STERILE	Amedic USA	1989-08-08	130
K892071	GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE	Amedic USA	1989-08-08	130
K892068	TRT (ACUSON) NEEDLE GUIDE KIT, STERILE	Amedic USA	1989-08-04	127
K871467	BIOPSY NEEDLE GUIDE KIT, STERILE	Amedic USA	1987-08-21	129
K871609	ULTRASOUND TRANSDUCER SHEATHS, STERILE	Amedic USA	1987-07-15	82
K871565	ULTRASOUND TRANSDUCER GEL, STERILE	Amedic USA	1987-07-15	84
K871503	BIOPSY NEEDLE GUIDE KIT, STERILE	Amedic USA	1987-07-10	84
K864219	TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE	Amedic USA	1987-03-27	150

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