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

KPM — Predicate Candidate Screening

19 FDA 510(k) clearances under this product code; the 50 most recent screened below.

89 daysmedian FDA review time

269 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days
K231096	Automatic Continuous Effusion Shunt (ACES) System ACES Syste	Pleural Dynamics, Inc.	2023-08-18	122
K170405	BD Curve Ascites Shunt	Care Fusion	2017-11-02	265
K012235	DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SH	Denver Biomedical, Inc.	2001-10-04	79
K011862	DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITI	Denver Biomedical, Inc.	2001-07-12	28
K011020	DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER	Denver Biomedicals, Inc.	2001-06-01	58
K003451	DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGL	Denver Biomedicals, Inc.	2001-01-02	56
K973129	DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACC	Denver Biomaterials, Inc.	1998-03-17	208
K962814	DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER	Denver Biomaterials, Inc.	1997-04-14	269
K913728	DENVER(R) PERITONEO-SUBCLAVIAN SHUNT	Denver Biomedicals, Inc.	1994-02-18	913
K901360	LEVEEN PERITINEO-VENOUS SHUNT	Bd Becton Dickinson Vacutainer Systems Preanalytic	1990-08-21	151
K894794	AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP	Vitaid, Ltd.	1989-11-21	116
K894756	DENVER PERITONEO-VENUS SHUNT	Codman & Shurtleff, Inc.	1989-09-29	64
K880570	DENVER PLEURO-PERITONEAL SHUNT	Codman & Shurtleff, Inc.	1988-06-20	131
K880401	DENVER PERITONEO-VENOUS SHUNT	Codman & Shurtleff, Inc.	1988-05-31	123
K842139	THE DENVER PLEURAL-PERITONEAL SHUNT	Denver Biomedicals, Inc.	1984-08-27	89
K822686	DENVER PERITONEO-VENOUS SHUNT (DP-VS)	Denver Biomedicals, Inc.	1982-09-21	18
K811183	DENVER PERITONEO-VENOUS SHUNT	Denver Biomedicals, Inc.	1981-07-01	63
K803258	CORDIS HAKIM ASCITES VALVE SYSTEM	Cordis Corp.	1981-01-15	23
K770602	VALVE, ASCITES, LAVEEN	Bd Becton Dickinson Vacutainer Systems Preanalytic	1977-04-15	16

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