Atlas FDA

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

Medical Plastics, Inc. — Predicate Candidate Screening

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

51 daysmedian FDA review time
102 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K902384ABDOMINAL OR C-SECTION DRAPE SHEETMedical Plastics, Inc.1990-08-09710
K896088FEMORAL ANGIOGRAPHY DRAPEMedical Plastics, Inc.1989-11-17290
K895404UNDER BUTTOCKS DRAPEMedical Plastics, Inc.1989-10-06290
K890101FEMORAL ANGIOGRAPHY DRAPEMedical Plastics, Inc.1989-03-16650
K822072MPI ELECTROSURGICAL CAPACTIVE DISPERMedical Plastics, Inc.1982-08-19360
K821169MPI MON-IT II, SMART SAFETY SYSTEMMedical Plastics, Inc.1982-08-061020
K781148ELECTROSURGICAL PENCIL SYSTEMMedical Plastics, Inc.1978-08-31510

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