Biosafety Systems, Inc.: FDA clearances and approvals
Biosafety Systems, Inc. has 8 FDA 510(k) clearances (first 1990, latest 1995), across 4 product codes in 2 review panels. Median 510(k) review time: 70 days.
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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 5 | 5 |
| CBN | Apparatus, Gas-Scavenging | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| LYZ | Vinyl Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (7)
- Anesthesiology (1)
Most recent Biosafety Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952274 | CHEMOGUARD, P2 HIRISK | FMI | 1995-08-29 | 106 |
| K944514 | P2 NITRILE EXAM GLOVES | LYZ | 1994-11-28 | 74 |
| K944142 | P2 EXAM GLOVES | LYY | 1994-10-28 | 64 |
| K944095 | P2 NITRILE EXAM GLOVES | LYY | 1994-10-28 | 67 |
| K921313 | AEROSTAR | CBN | 1992-09-11 | 177 |
| K904130 | CHEMO GLOVES POWDER FREE (MFG: UNION INDUSTRIAL) | LYY | 1990-10-10 | 35 |
| K901411 | CHEMOPLUS GLOVE | LYY | 1990-06-07 | 73 |
| K900368 | P2/CHEMO PLUS GLOVES | LYY | 1990-03-08 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Biosafety Systems, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Biosafety Systems, Inc. have?
Biosafety Systems, Inc. has 8 FDA 510(k) clearances (first 1990, latest 1995), across 4 product codes in 2 review panels.
How long does FDA take to clear Biosafety Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Biosafety Systems, Inc.'s cleared 510(k)s is 70 days.
What devices does Biosafety Systems, Inc. make?
Its most frequent FDA product codes are LYY (Latex Patient Examination Glove, 5); CBN (Apparatus, Gas-Scavenging, 1); FMI (Needle, Hypodermic, Single Lumen, 1).
Has Biosafety Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Biosafety Systems, Inc. Related entities may recall under other names.
Next steps
- See all 8 Biosafety Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Biosafety Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.