Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Denver Biomedicals, Inc. · Predicate Candidate Screening

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

63 daysmedian FDA review time
913 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K051084DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WDenver Biomedicals, Inc.2005-06-13460
K011020DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBERDenver Biomedicals, Inc.2001-06-01580
K010642PLEURX PLEURAL CATHETER AND DRAINAGE KITSDenver Biomedicals, Inc.2001-03-20150
K003451DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLDenver Biomedicals, Inc.2001-01-02560
K943968TUNNELERDenver Biomedicals, Inc.1995-03-011980
K913728DENVER(R) PERITONEO-SUBCLAVIAN SHUNTDenver Biomedicals, Inc.1994-02-189130
K842139THE DENVER PLEURAL-PERITONEAL SHUNTDenver Biomedicals, Inc.1984-08-27890
K822686DENVER PERITONEO-VENOUS SHUNT (DP-VS)Denver Biomedicals, Inc.1982-09-21180
K811577CROUCH CORNEAL PROTECTORDenver Biomedicals, Inc.1981-08-07630
K811183DENVER PERITONEO-VENOUS SHUNTDenver Biomedicals, Inc.1981-07-01630

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