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

International Medsurg Connection · Predicate Candidate Screening

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

128 daysmedian FDA review time

164 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K110656	IMC BLOOD COLLECTION NEEDLE	International Medsurg Connection	2011-08-18	164	0
K110882	IMC INSULIN SYRINGE	International Medsurg Connection	2011-08-18	141	0
K102584	IMC HYPODERMIC NEEDLE	International Medsurg Connection	2011-01-14	128	0
K102969	IMC PISTON SYRINGES	International Medsurg Connection	2010-12-20	75	2
K100991	IMC SURGICAL DRAPE	International Medsurg Connection	2010-10-05	179	0
K100846	IMC SURGICAL FACE MASK	International Medsurg Connection	2010-08-16	144	0
K100208	IMC SURGICAL DRAPE	International Medsurg Connection	2010-04-20	85	0
K023808	IRRIGATION SETS	International Medsurg Connection	2003-03-10	116	0
K022159	PISTON SYRINGE & HYPODERMIC NEEDLE	International Medsurg Connection	2002-11-07	128	0
K014239	MEDSURG EQUIPMENT COVERS	International Medsurg Connection	2002-02-19	55	0
K971159	SURGICAL DRAPES	International Medsurg Connection	1997-06-24	85	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