General Atomics: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “General Atomics” (first 2003, latest 2009), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 138 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 |
|---|---|---|---|
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 1 | 1 |
| JII | Atomic Absorption, Lithium | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
| LBR | Ldl & Vldl Precipitation, Hdl | 1 | 1 |
| LCP | Assay, Glycosylated Hemoglobin | 1 | 1 |
| MSJ | Apolipoproteins | 1 | 1 |
Review panels
- Clinical Chemistry (3)
- Hematology (1)
- Immunology (1)
- Clinical Toxicology (1)
Most recent General Atomics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082488 | DIAZYME LP(A) ASSAY | DFC | 2009-01-13 | 138 |
| K072977 | DIAZYME APOLIPOPROTEIN A-1 ASSAY | MSJ | 2008-07-16 | 268 |
| K072523 | DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS | LBR | 2008-01-22 | 137 |
| K050178 | HBA1C ENZYMATIC ASSAY | LCP | 2005-06-28 | 153 |
| K042448 | DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT | JJX | 2004-10-29 | 50 |
| K033360 | DIAZYME LITHIUM ENZYMATIC ASSAY KIT | JII | 2003-12-23 | 63 |
Recalls
openFDA lists no recalls under a recalling firm named General Atomics.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- General Electric Co. (254 510(k)s)
- General Diagnostics (39 510(k)s)
- General Electric Medical Systems Information Techn (33 510(k)s)
- General Biometrics, Inc. (23 510(k)s)
- General Medical Co. (15 510(k)s)
- General Surgical Innovations (14 510(k)s)
- General X-Ray, Inc. (14 510(k)s)
- General Devices (13 510(k)s)
- General Physiotherapy, Inc. (9 510(k)s)
- General Medical Merate S.P.A (7 510(k)s)
- General Theraphysical, Inc. (7 510(k)s)
- General Electric Medical Systems (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under General Atomics?
FDA lists 6 510(k) clearances under the applicant name “General Atomics” (first 2003, latest 2009), across 6 product codes in 4 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 General Atomics?
The median time from FDA receipt to decision across 510(k)s cleared under the name General Atomics is 138 days.
Which FDA product codes appear under General Atomics?
The most frequent FDA product codes under this applicant name are DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control, 1); JII (Atomic Absorption, Lithium, 1); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 1).
Next steps
- See all 6 General Atomics clearances with predicates and recalls
- Run predicate analysis for product code DFC, General Atomics'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.