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

Strato/Infusaid, Inc. · Predicate Candidate Screening

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

83 daysmedian FDA review time

156 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K960391	STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771	Strato/Infusaid, Inc.	1996-07-03	156	0
K953529	STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM	Strato/Infusaid, Inc.	1996-01-26	183	1
K954720	STRATO/INFUSAIF INFUSE-A-CATH CENTRAL VENOUS CATHETERS	Strato/Infusaid, Inc.	1996-01-04	83	0
K953254	STRATO/INFUSAID INFUSE-A-KIT	Strato/Infusaid, Inc.	1995-11-29	140	0
K953436	STRATO/INFUSAID INFUSE-A-CATH SINGLE LUMEN SILICONE CENTRAL	Strato/Infusaid, Inc.	1995-10-04	75	0
K953256	STRATO/INFUSAID INFUS-A-CATH DUAL LUMEN PREATTACHED SILICONE	Strato/Infusaid, Inc.	1995-10-04	84	0
K950987	STRATO/INFUSAID TUNNELER	Strato/Infusaid, Inc.	1995-06-02	91	0
K951875	STRATO/INFUSAID BUTTON PORT VASCULAR ACC. SYSTEM	Strato/Infusaid, Inc.	1995-05-24	33	0
K951874	STRATO/INFUSAID MACROPORT VASCULAR ACC. SYSTEM	Strato/Infusaid, Inc.	1995-05-19	28	0
K951873	STRATO/INFUSAIND MICROPORT VASCULAR ACC. SYSTEM	Strato/Infusaid, Inc.	1995-05-19	28	0
K951872	STRATO/INFUSAID DUALPORT VASCULAR ACC. SYSTEM	Strato/Infusaid, Inc.	1995-05-18	27	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