Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Microvasive — Predicate Candidate Screening

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

59 daysmedian FDA review time

252 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K872771	LOW PROFILE GASTROSTOMY	Microvasive	1987-10-09	87	0
K870705	THERMAL COAGULATOR	Microvasive	1987-04-17	56	0
K861309	JEJUNAL FEEDING TUBE	Microvasive	1986-12-16	252	0
K861323	REPLACEMENT GASTROSTOMY TUBE	Microvasive	1986-12-16	252	21
K860366	CHALLENGER HOT BIOPSY FORCEPS	Microvasive	1986-04-07	63	0
K860589	INFLATOR/DEFLATOR PISTON SYRINGE	Microvasive	1986-04-07	47	0
K854238	NEEDLE W/STYLET FOR IMPLANTATION	Microvasive	1985-11-13	23	0
K854063	MICROVASIVE SILICONE SPRAY	Microvasive	1985-10-25	21	0
K851652	PAPILLOTOME	Microvasive	1985-06-24	63	0
K850393	FLEXIBLE FIBEROPTIC ENDOSCOPE	Microvasive	1985-06-04	123	0
K844769	RIGID FIBEROPITC ENDOSCOPE	Microvasive	1985-01-15	39	0
K841330	GASTROSTOMY FEEDING TUBE	Microvasive	1984-05-22	50	0
K834468	DRAINAGE STENT	Microvasive	1984-04-20	122	2
K840033	HYPODERMIC NEEDLES & STYLETS	Microvasive	1984-04-05	91	2
K834467	SPECIMEN TRAP	Microvasive	1984-02-17	59	0
K833417	ENDOSCOPIC RETROGRADE	Microvasive	1983-11-28	56	0
K833330	MUTO BRUSH	Microvasive	1983-11-14	48	0
K833331	ASPIRATION & IRRIGATION CATHETER	Microvasive	1983-11-14	48	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