Safety Syringes, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Safety Syringes, Inc.” (first 1995, latest 2013), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 63 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 | 1 | 29 |
| 2013 | 1 | 110 |
| 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 |
|---|---|---|---|
| MEG | Syringe, Antistick | 7 | 7 |
| FMF | Syringe, Piston | 3 | 3 |
Review panels
- General Hospital (10)
Most recent Safety Syringes, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123743 | ULTRASAFE PLUS PASSIVE NEEDLE GUARD | MEG | 2013-03-26 | 110 |
| K122558 | ULTRASAFE PASSIVE NEEDLE GUARD | MEG | 2012-09-20 | 29 |
| K060743 | MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES) | MEG | 2006-04-28 | 39 |
| K042712 | TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM | MEG | 2004-10-15 | 15 |
| K013801 | ULTRASAFE DENTAL INJECTION SYSTEM | MEG | 2001-12-13 | 28 |
| K011369 | ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY) | MEG | 2001-05-29 | 25 |
| K972900 | ULTRASAFE MODEL T200 INJECTOR | FMF | 1998-02-26 | 204 |
| K972877 | ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD | FMF | 1998-02-26 | 206 |
| K972878 | ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300 | FMF | 1997-10-30 | 87 |
| K944425 | ULTRASAFE ASPIRATING SYRINGE | MEG | 1995-01-26 | 136 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2002-09-05.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Safety Laboratories West (2 510(k)s)
- Safety Medical International, Incorporated (2 510(k)s)
- Safety 1st, Inc. (1 510(k)s)
- Safety 1st Medical, Inc. (1 510(k)s)
- Safety Diagnostics, Inc. (1 510(k)s)
- Safety Intl., Inc. (1 510(k)s)
- Safety Medical Supply Int,., Inc. (1 510(k)s)
- Safety Plastics of New York (1 510(k)s)
- Safety Rehab Systems, Inc. (1 510(k)s)
- Safety Sea Systems, Inc. (1 510(k)s)
- Safety Supply House of Louisiana, Inc. (1 510(k)s)
- Safety Tek Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Safety Syringes, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Safety Syringes, Inc.” (first 1995, latest 2013), 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 Safety Syringes, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Safety Syringes, Inc. is 63 days.
Which FDA product codes appear under Safety Syringes, Inc.?
The most frequent FDA product codes under this applicant name are MEG (Syringe, Antistick, 7); FMF (Syringe, Piston, 3).
Next steps
- See all 10 Safety Syringes, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MEG, Safety Syringes, 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.