Atlas FDA

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

Pro-Tec Containers, Inc. — Predicate Candidate Screening

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

47 daysmedian FDA review time
212 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K945274PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80Pro-Tec Containers, Inc.1994-12-14470
K945273PRO-TECH DISPOSABLE SHARPS CONTAINERS VNC2Pro-Tec Containers, Inc.1994-12-14470
K945275PRO-TEC DISPOSBLE SHARPS CONTAINERS Q1Pro-Tec Containers, Inc.1994-12-14470
K945276PRO-TEC DISPOSABLE SHARPS CONTAINERS 5GPro-Tec Containers, Inc.1994-12-14470
K942179PRO-TEC DISPOSABLE SHARPS CONTAINERSPro-Tec Containers, Inc.1994-12-022120
K892665PRO-JECT(TM) SAFETY NEEDLE HOLDERPro-Tec Containers, Inc.1989-10-041740

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