Survival Technology, Inc.: FDA clearances and approvals
Survival Technology, Inc. has 10 FDA 510(k) clearances (first 1977, latest 1993), across 4 product codes in 2 review panels. Median 510(k) review time: 52 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 |
|---|---|---|---|
| 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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Survival Technology, Inc.'s product codes (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 does Survival Technology, Inc. have?
Survival Technology, Inc. has 10 FDA 510(k) clearances (first 1977, latest 1993), across 4 product codes in 2 review panels.
How long does FDA take to clear Survival Technology, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Survival Technology, Inc.'s cleared 510(k)s is 52 days.
What devices does Survival Technology, Inc. make?
Its most frequent FDA product codes are DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 7); DXG (Computer, Diagnostic, Pre-Programmed, Single-Function, 1); DXY (Implantable Pacemaker Pulse-Generator, 1).
Has Survival Technology, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Survival Technology, Inc. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.