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

Inrad — Predicate Candidate Screening

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

61 daysmedian FDA review time

90 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K093399	PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 6	Inrad	2009-11-19	17	0
K093256	SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514	Inrad	2009-11-17	29	0
K090611	REVOLUTION FULL CORE BIOPSY	Inrad	2009-06-04	90	0
K063238	ULTRACLIP II WING AND ULTRACLIP II COIL	Inrad	2007-01-30	96	0
K042341	ULTRACLIP II US	Inrad	2004-09-20	21	0
K041201	ULTRACLIP II MR	Inrad	2004-06-03	27	0
K000612	ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE	Inrad	2000-04-24	61	0
K993785	ULTRACLIP TISSUE MARKER	Inrad	2000-02-04	88	1
K981721	C0-AXIAL INTRODUCER NEEDLE	Inrad	1998-07-28	74	0
K981166	ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 58	Inrad	1998-06-22	83	0
K980587	IV DECANTER-FLEXIBLE	Inrad	1998-04-17	59	0

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