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

River Medical, Inc. — Predicate Candidate Screening

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

177 daysmedian FDA review time

435 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K023174	DISPOSABLE TEMPORARY PACING WIRE	River Medical, Inc.	2003-06-11	261
K944351	SMARTDOSE IV PREFILLED INFUSION CONTAINER	River Medical, Inc.	1995-11-15	435
K944352	SMARTDOSE III INFUSION CONTAINER	River Medical, Inc.	1995-11-15	435
K945298	SMARTFLOW I ADMINISTRATION SET	River Medical, Inc.	1995-06-14	226
K943692	SMART DOSE(TM)	River Medical, Inc.	1995-04-28	274
K932895	RIVER PUMP	River Medical, Inc.	1994-03-31	290
K933335	RIVER VIAL ADAPTER	River Medical, Inc.	1994-03-01	236
K915120	TEF/PLATINUM PISTON	River Medical, Inc.	1991-12-27	44
K915121	TEF/WIRE PISTON	River Medical, Inc.	1991-12-23	40
K913286	H/A TOTAL-REGULAR, H/A TOTAL-OFFSET	River Medical, Inc.	1991-12-18	147
K913287	H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET	River Medical, Inc.	1991-12-18	147
K913285	PTFE PISTON	River Medical, Inc.	1991-12-18	147
K905437	RIVER MEDICAL MICRODRILL SYSTEM	River Medical, Inc.	1991-05-30	177
K904597	GROMMET STYLE VENTURI	River Medical, Inc.	1991-01-28	110
K904594	COLLAR BUTTON STYLE VENTURI	River Medical, Inc.	1991-01-28	110
K904592	BOBBIN STYLE VENTURI	River Medical, Inc.	1991-01-28	110

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