Atlas FDA

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

Molded Products, Inc. — Predicate Candidate Screening

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

266 daysmedian FDA review time
415 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K022068TUBING, DIALYSATE (AND CONNECTOR)Molded Products, Inc.2002-09-23900
K010366DISPOSABLE STORAGE CAPMolded Products, Inc.2001-11-282940
K010712DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINESMolded Products, Inc.2001-09-272020
K003712MODIFICATION TO MALE TO MALE LUER ADAPTERMolded Products, Inc.2001-05-161662
K925978MPC-80 TRANSDUCERMolded Products, Inc.1994-01-144150
K925930MPC-150 MALE TO MALE LUER ADAPTERMolded Products, Inc.1993-08-162660
K925927MPC-1000 INJECTION CAP/PLUGMolded Products, Inc.1993-08-162661

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