Survivalink Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Survivalink Corp.” (first 1995, latest 2002), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 141 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 |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | 6 | 6 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 1 | 1 |
Review panels
- Cardiovascular (7)
Most recent Survivalink Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011901 | FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200 | MKJ | 2002-02-01 | 228 |
| K010214 | FIRSTSAVE BIPHASIC MODEL #9200 AND 9210 | MKJ | 2001-02-22 | 30 |
| K993072 | SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630) | MKJ | 1999-12-10 | 87 |
| K982264 | FIRSTSAVE BIPHASIC MODELS 9200 AND 9210 | MKJ | 1999-01-25 | 210 |
| K970481 | V2 | LDD | 1997-07-01 | 141 |
| K971149 | SVL-9130 DEFIBRILLATION ELECTRODE | MKJ | 1997-06-23 | 87 |
| K940445 | VIVALINK AED DEFIBRILLATOR | MKJ | 1995-02-09 | 373 |
Recalls
openFDA lists no recalls under a recalling firm named Survivalink Corp..
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 Survivalink Corp.?
FDA lists 7 510(k) clearances under the applicant name “Survivalink Corp.” (first 1995, latest 2002), 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 Survivalink Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Survivalink Corp. is 141 days.
Which FDA product codes appear under Survivalink Corp.?
The most frequent FDA product codes under this applicant name are MKJ (Automated External Defibrillators (Non-Wearable), 6); LDD (Dc-Defibrillator, Low-Energy, (Including Paddles), 1).
Next steps
- See all 7 Survivalink Corp. clearances with predicates and recalls
- Run predicate analysis for product code MKJ, Survivalink Corp.'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.