U.S. Safety Syringes Co., Inc.: FDA clearances and approvals
U.S. Safety Syringes Co., Inc. has 7 FDA 510(k) clearances (first 2000, latest 2009), across 4 product codes in 1 review panel. Median 510(k) review time: 64 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 3 | 3 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| MEG | Syringe, Antistick | 1 | 1 |
Review panels
- General Hospital (7)
Most recent U.S. Safety Syringes Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090502 | NOVA SAFE SCALP VEIN BLOOD COLLECTION SET | FOZ | 2009-03-10 | 13 |
| K090122 | NUOVOGUARD | FOZ | 2009-02-05 | 15 |
| K083454 | NUOVOCATH | FOZ | 2008-12-04 | 13 |
| K080665 | NOVOLET | FPA | 2008-05-13 | 64 |
| K080660 | IV ADMINISTRATION SET | FPA | 2008-05-13 | 64 |
| K003381 | SHIELDING NEEDLE HOLDER | FMI | 2001-04-23 | 174 |
| K990831 | SUPERGUARD SAFETY SYRINGE | MEG | 2000-03-08 | 362 |
Recalls
openFDA lists no recalls under a recalling firm named U.S. Safety Syringes Co., 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 U.S. Safety Syringes Co., Inc. have?
U.S. Safety Syringes Co., Inc. has 7 FDA 510(k) clearances (first 2000, latest 2009), across 4 product codes in 1 review panel.
How long does FDA take to clear U.S. Safety Syringes Co., Inc.'s 510(k)s?
The median time from FDA receipt to decision across U.S. Safety Syringes Co., Inc.'s cleared 510(k)s is 64 days.
What devices does U.S. Safety Syringes Co., Inc. make?
Its most frequent FDA product codes are FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 3); FPA (Set, Administration, Intravascular, 2); FMI (Needle, Hypodermic, Single Lumen, 1).
Has U.S. Safety Syringes Co., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching U.S. Safety Syringes Co., Inc. Related entities may recall under other names.
Next steps
- See all 7 U.S. Safety Syringes Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code FOZ, U.S. Safety Syringes Co., 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.