Atlas FDA

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

Premium Plastics, Inc. — Predicate Candidate Screening

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

58 daysmedian FDA review time
286 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K953226PULM O2 SUCTION CATHETER TRAYSPremium Plastics, Inc.1995-08-08330
K950851GENT-L-KARE TRACHEOSTOMY TRAYSPremium Plastics, Inc.1995-06-211170
K950850GENT-L-KARE LACERATION TRAYSPremium Plastics, Inc.1995-03-14180
K943740ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)Premium Plastics, Inc.1994-12-141340
K890107GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KITPremium Plastics, Inc.1989-10-242860
K893135GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATERPremium Plastics, Inc.1989-06-22580
K850285GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAYPremium Plastics, Inc.1985-02-28360
K800440STERILE SPONGE BOWLSPremium Plastics, Inc.1980-04-29610
K771448STERILE SUTURE REMOVAL KITPremium Plastics, Inc.1977-09-06350

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