Survival Technology, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Survival Technology, Inc.” (first 1977, latest 1993), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 52 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 |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 7 | 7 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 | 1 |
| DXY | Implantable Pacemaker Pulse-Generator | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
Review panels
- Cardiovascular (9)
- General Hospital (1)
Most recent Survival Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K925535 | CARDIOBEEPER(R) CB-IIA | DXH | 1993-01-28 | 87 |
| K894799 | CARDIOBEEPER MEMORY MONITOR CB 600 SERIES | DXH | 1989-10-03 | 67 |
| K890461 | CARDIOBEEPER IV | DXH | 1989-02-23 | 24 |
| K883843 | CARDIOBEEPER II | DXH | 1988-11-09 | 58 |
| K883614 | CYTOGUARD(R) | FMF | 1988-09-15 | 22 |
| K880300 | CARDIOBEEPER(R) III | DXH | 1988-05-12 | 108 |
| K844966 | CARDIOBEEPER PROFILE MONITOR | DXH | 1985-02-08 | 46 |
| K822093 | STAT-SCAN | DXG | 1982-09-21 | 67 |
| K813101 | CARDIOBEEPER MEMORY MONITOR | DXY | 1981-11-27 | 24 |
| K772178 | PACER MONITOR, PULSE WIDTH | DXH | 1977-12-08 | 16 |
Recalls
openFDA lists no recalls under a recalling firm named Survival Technology, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Survival Technology, Inc. (a text match, not an official crosswalk):
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via DXY)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
Frequently asked questions
How many FDA 510(k) clearances are listed under Survival Technology, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Survival Technology, Inc.” (first 1977, latest 1993), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Survival Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Survival Technology, Inc. is 52 days.
Which FDA product codes appear under Survival Technology, Inc.?
The most frequent FDA product codes under this applicant name are DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 7); DXG (Computer, Diagnostic, Pre-Programmed, Single-Function, 1); DXY (Implantable Pacemaker Pulse-Generator, 1).
Next steps
- See all 10 Survival Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXH, Survival Technology, 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.