La Jolla Technology, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “La Jolla Technology, Inc.” (first 1983, latest 1987), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 81 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 |
|---|---|---|---|
| GXY | Electrode, Cutaneous | 2 | 2 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 2 | 2 |
| DPS | Electrocardiograph | 1 | 1 |
Review panels
- Neurology (4)
- Cardiovascular (1)
Most recent La Jolla Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K870160 | DYNEX DISPOSABLE SELF-ADHERING ELECTRODE W/TENS | GXY | 1987-04-01 | 78 |
| K864956 | DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA. | GZJ | 1987-03-09 | 81 |
| K854204 | DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENS | GXY | 1986-01-10 | 86 |
| K832888 | ECG INTERFERENCE FILTER TF-03 | DPS | 1984-01-18 | 145 |
| K830932 | NYNEX II | GZJ | 1983-04-18 | 26 |
Recalls
openFDA lists no recalls under a recalling firm named La Jolla 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under La Jolla Technology, Inc.?
FDA lists 5 510(k) clearances under the applicant name “La Jolla Technology, Inc.” (first 1983, latest 1987), across 3 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 La Jolla Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name La Jolla Technology, Inc. is 81 days.
Which FDA product codes appear under La Jolla Technology, Inc.?
The most frequent FDA product codes under this applicant name are GXY (Electrode, Cutaneous, 2); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 2); DPS (Electrocardiograph, 1).
Next steps
- See all 5 La Jolla Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GXY, La Jolla 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.