Med-Safe Systems, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Med-Safe Systems, Inc.” (first 1994, latest 1994), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 131 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 7 | 7 |
| MMK | Container, Sharps | 1 | 1 |
Review panels
- General Hospital (8)
Most recent Med-Safe Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943139 | B-D GUARDIAN ONE PIECE SHARPS COLLECTORS | FMI | 1994-11-28 | 152 |
| K943138 | VACUTAINER BRAND NEEDLE DISPOSAL CONTAINER | MMK | 1994-11-28 | 152 |
| K943141 | B-D GUARDIAN POINT OF USE HORIZONTAL AND SIDE ENTRY SHARPS COLLECTORS | FMI | 1994-11-07 | 131 |
| K943140 | B-D GURADIAN CHEMOTHERAPY SHARPS COLLECTORS | FMI | 1994-11-07 | 131 |
| K943137 | B-D/BFI MAIL DISPOSAL SERVICE | FMI | 1994-11-07 | 131 |
| K943136 | B-D GUARDIAN POINT-OF-USE VERTICAL ENTRY SHARPS COLLECTORS | FMI | 1994-11-07 | 131 |
| K943135 | MED-SAFE INSULIN SHARPS CONTAINER | FMI | 1994-11-07 | 131 |
| K943134 | B-D GUARDIAN NESTABLE SHARPS COLLECTORS | FMI | 1994-11-07 | 131 |
Recalls
openFDA lists no recalls under a recalling firm named Med-Safe Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Med-Safe Systems, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Med-Safe Systems, Inc.” (first 1994, latest 1994), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Med-Safe Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Med-Safe Systems, Inc. is 131 days.
Which FDA product codes appear under Med-Safe Systems, Inc.?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 7); MMK (Container, Sharps, 1).
Next steps
- See all 8 Med-Safe Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Med-Safe Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.