Kronus, Inc.: FDA clearances and approvals
Kronus, Inc. has 8 FDA 510(k) clearances (first 1989, latest 2023), plus 1 De Novo decision, across 4 product codes in 1 review panel. Median 510(k) review time: 119 days. Since 2017 its median was 261 days, against 262 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 7 |
| 2017 | 0 | — |
| 2018 | 2 | 241 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 590 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Kronus, Inc.'s cleared 510(k)s took a median 261 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 262 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JZO | System, Test, Thyroid Autoantibody | 4 | 4 |
| OIF | Tyrosine Phosphatase (Ia-2) Autoantibody Assay | 2 | 2 |
| PNI | Aquaporin-4 Autoantibody | 2 | 1 |
| PCG | 21-Hydroxylase Antibody (21-Ohab) | 1 | 1 |
Review panels
- Immunology (9)
Most recent Kronus, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220085 | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit | OIF | 2023-08-24 | 590 |
| K180607 | Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit | PCG | 2018-11-23 | 261 |
| K171731 | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit | OIF | 2018-01-19 | 221 |
| K161951 | KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay | PNI | 2016-07-22 | 7 |
| K915429 | KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KIT | JZO | 1992-03-30 | 119 |
| K915428 | KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT | JZO | 1992-03-30 | 119 |
| K894364 | MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) | JZO | 1989-07-25 | 11 |
| K894203 | ANTI-THYROGLOBULIN TEST KIT | JZO | 1989-07-25 | 36 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN150030 | De Novo | Aquaporin-4 Autoantibody | 2016-04-25 |
Recalls
openFDA lists no recalls under a recalling firm named Kronus, 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.
Frequently asked questions
How many FDA 510(k) clearances does Kronus, Inc. have?
Kronus, Inc. has 8 FDA 510(k) clearances (first 1989, latest 2023), plus 1 De Novo decision, across 4 product codes in 1 review panel.
How long does FDA take to clear Kronus, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Kronus, Inc.'s cleared 510(k)s is 119 days. Since 2017: 261 days, versus 262 days for all cleared 510(k)s in the same product codes.
What devices does Kronus, Inc. make?
Its most frequent FDA product codes are JZO (System, Test, Thyroid Autoantibody, 4); OIF (Tyrosine Phosphatase (Ia-2) Autoantibody Assay, 2); PNI (Aquaporin-4 Autoantibody, 2).
Has Kronus, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Kronus, Inc. Related entities may recall under other names.
Next steps
- See all 8 Kronus, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JZO, Kronus, 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.