Atlas FDA

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

Pharma-Plast USA, Inc. — Predicate Candidate Screening

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

100 daysmedian FDA review time
203 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K894371NIPRO SAFELET CATHPharma-Plast USA, Inc.1989-10-251000
K894373NIPRO DENTAL NEEDLEPharma-Plast USA, Inc.1989-10-13880
K894372NIPRO NEEDLE HOLDERPharma-Plast USA, Inc.1989-09-28730
K894374BLOOD DRAWING NEEDLEPharma-Plast USA, Inc.1989-09-28730
K884978PHARMA-PLAST INSULIN INFUSION SETPharma-Plast USA, Inc.1989-06-212030
K871263MULTIPLE PHARMA-PLAST TRACHEAL TUBEPharma-Plast USA, Inc.1987-06-15760
K852443PHARMA-PLAST CLINIPAKPharma-Plast USA, Inc.1985-10-161280
K852444ASIK 'ONCE' SYRINGEPharma-Plast USA, Inc.1985-10-161280
K852442PHARMA-PLAST NEEDLEPharma-Plast USA, Inc.1985-09-201020

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