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

Ranfac, Corp. — Predicate Candidate Screening

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

91 daysmedian FDA review time

181 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K162932	Ranfac Fat Aspiration Cannula	Ranfac, Corp.	2017-01-19	91
K150156	Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack	Ranfac, Corp.	2015-10-19	269
K150563	Marrow Cellution Bone Marrow Aspiration Needle	Ranfac, Corp.	2015-05-22	77
K140991	RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE	Ranfac, Corp.	2014-09-11	147
K131157	RANFAC BONE MARROW ASPIRATION NEEDLE	Ranfac, Corp.	2013-10-22	181
K031344	RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE	Ranfac, Corp.	2003-05-23	24
K012224	SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH	Ranfac, Corp.	2001-08-22	67
K961922	RDP-2	Ranfac, Corp.	1996-08-09	84
K951090	INTRODUCER	Ranfac, Corp.	1995-07-11	124
K930474	NEEDLE, PNEUMOPERITONEUM, SPRING LOADED	Ranfac, Corp.	1993-07-23	176
K864139	RANFAC CUT BIOPSY NEEDLE	Ranfac, Corp.	1986-11-05	14
K845038	BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT	Ranfac, Corp.	1985-03-11	74

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