Life-Shield Products, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Life-Shield Products, Inc.” (first 2003, latest 2007), across 1 product code 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 | 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 |
|---|---|---|---|
| MEG | Syringe, Antistick | 5 | 5 |
Review panels
- General Hospital (5)
Most recent Life-Shield Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K072037 | CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML | MEG | 2007-08-08 | 14 |
| K061055 | CAREO SAFETY SYRINGE FOR U-100 INSULIN | MEG | 2006-07-10 | 84 |
| K060208 | CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C, | MEG | 2006-03-10 | 42 |
| K052397 | CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML) | MEG | 2005-12-22 | 113 |
| K030976 | CAREO RETRACTABLE SAFETY SYRINGE | MEG | 2003-05-30 | 63 |
Recalls
openFDA lists no recalls under a recalling firm named Life-Shield Products, 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 Life-Shield Products, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Life-Shield Products, Inc.” (first 2003, latest 2007), across 1 product code 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 Life-Shield Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Life-Shield Products, Inc. is 63 days.
Which FDA product codes appear under Life-Shield Products, Inc.?
The most frequent FDA product codes under this applicant name are MEG (Syringe, Antistick, 5).
Next steps
- See all 5 Life-Shield Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MEG, Life-Shield Products, 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.