Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Med-Safe Systems, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
131 daysmedian FDA review time
152 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K943138 | VACUTAINER BRAND NEEDLE DISPOSAL CONTAINER | Med-Safe Systems, Inc. | 1994-11-28 | 152 | 0 |
| K943139 | B-D GUARDIAN ONE PIECE SHARPS COLLECTORS | Med-Safe Systems, Inc. | 1994-11-28 | 152 | 0 |
| K943136 | B-D GUARDIAN POINT-OF-USE VERTICAL ENTRY SHARPS COLLECTORS | Med-Safe Systems, Inc. | 1994-11-07 | 131 | 0 |
| K943137 | B-D/BFI MAIL DISPOSAL SERVICE | Med-Safe Systems, Inc. | 1994-11-07 | 131 | 0 |
| K943135 | MED-SAFE INSULIN SHARPS CONTAINER | Med-Safe Systems, Inc. | 1994-11-07 | 131 | 0 |
| K943134 | B-D GUARDIAN NESTABLE SHARPS COLLECTORS | Med-Safe Systems, Inc. | 1994-11-07 | 131 | 0 |
| K943141 | B-D GUARDIAN POINT OF USE HORIZONTAL AND SIDE ENTRY SHARPS C | Med-Safe Systems, Inc. | 1994-11-07 | 131 | 0 |
| K943140 | B-D GURADIAN CHEMOTHERAPY SHARPS COLLECTORS | Med-Safe Systems, Inc. | 1994-11-07 | 131 | 0 |
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