Zeus Scientific, Inc.: FDA filings under this applicant name
FDA lists 142 510(k) clearances under 2 spellings of the applicant name “Zeus Scientific, Inc.” (first 1976, latest 2026), plus 3 PMA decisions, across 52 product codes in 4 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 112 days, against 179 days for all cleared 510(k)s in the same product codes. 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 | 1 | 252 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 3 | 82 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 654 |
| 2023 | 2 | 98 |
| 2024 | 0 | — |
| 2025 | 3 | 218 |
| 2026 | 2 | 263 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zeus Scientific, Inc. took a median 112 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 179 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | 13 | 13 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 9 | 9 |
| MID | System, Test, Anticardiolipin Immunological | 9 | 9 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 9 | 9 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 6 | 6 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 6 | 6 |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 5 | 5 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 5 | 5 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 5 | 5 |
| LSE | Epstein-Barr Virus, Other | 5 | 5 |
Plus 42 more product codes.
Review panels
- Microbiology (75)
- Immunology (66)
- Pathology (2)
- Clinical Chemistry (1)
Most recent Zeus Scientific, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM | MOB | 2026-08-21 | 109 |
| K250814 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB | OBE | 2026-05-08 | 417 |
| K250666 | Alegria Flash CTD Screen | LLL | 2025-10-22 | 231 |
| K250408 | Alegria Flash ENA Screen | LLL | 2025-09-19 | 218 |
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) | MOB | 2025-05-07 | 149 |
| K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFine | KTL | 2023-08-31 | 90 |
| K230863 | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit | LSR | 2023-07-13 | 106 |
| K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFine | DHN | 2022-04-29 | 654 |
| K191398 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System | LSR | 2019-07-29 | 66 |
| K191240 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System | LSR | 2019-07-29 | 82 |
132 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P150045 | PMA | ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM | 2017-09-19 |
| P150042 | PMA | ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM | 2017-09-19 |
| P900025 | PMA | FLUORO-CEP (R) PROGESTERONE | 1990-09-26 |
Recalls
12 product recalls in 11 recall events; 2 initiated in the last five years. Most recent: 2023-10-31.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Zeus Scientific, Inc. (138)
- Zeus Scientific (7)
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.
- Zeus Technologies (4 510(k)s)
- Zeus Scientific, Inc. (Zeus) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zeus Scientific, Inc.?
FDA lists 142 510(k) clearances under 2 spellings of the applicant name “Zeus Scientific, Inc.” (first 1976, latest 2026), plus 3 PMA decisions, across 52 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 Zeus Scientific, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zeus Scientific, Inc. is 90 days. Since 2017: 112 days, versus 179 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zeus Scientific, Inc.?
The most frequent FDA product codes under this applicant name are LSR (Reagent, Borrelia Serological Reagent, 13); LLL (Extractable Antinuclear Antibody, Antigen And Control, 9); MID (System, Test, Anticardiolipin Immunological, 9).
Next steps
- See all 142 Zeus Scientific, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LSR, Zeus Scientific, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.