Randox Laboratories, Ltd.: FDA filings under this applicant name
FDA lists 133 510(k) clearances under 2 spellings of the applicant name “Randox Laboratories, Ltd.” (first 1992, latest 2026), plus 1 De Novo decision, across 77 product codes in 4 review panels. Median 510(k) review time under this name: 124 days. Since 2017 the median was 270 days, against 169 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 | 8 | 184 |
| 2013 | 6 | 68 |
| 2014 | 5 | 79 |
| 2015 | 2 | 166 |
| 2016 | 4 | 172 |
| 2017 | 3 | 266 |
| 2018 | 1 | 85 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 3 | 492 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 318 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Randox Laboratories, Ltd. took a median 270 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 169 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 15 | 15 |
| DJG | Enzyme Immunoassay, Opiates | 5 | 5 |
| JIX | Calibrator, Multi-Analyte Mixture | 5 | 5 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 5 | 5 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 3 | 3 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 3 | 3 |
| DJR | Enzyme Immunoassay, Methadone | 3 | 3 |
| JIS | Calibrator, Primary | 3 | 3 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 3 | 3 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 | 2 |
Plus 67 more product codes.
Review panels
- Clinical Chemistry (80)
- Clinical Toxicology (34)
- Immunology (16)
- Hematology (4)
Most recent Randox Laboratories, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250741 | Evidence MultiSTAT DOA Urine MultiPlex | DJG | 2026-01-23 | 318 |
| K221550 | Evidence MultiSTAT DOA Urine MultiPlex | DJG | 2023-10-05 | 492 |
| K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | DJG | 2023-10-05 | 595 |
| K230890 | ISE Electrodes | CEM | 2023-09-08 | 161 |
| K182042 | Randox Calcium (Ca) | CJY | 2018-10-23 | 85 |
| K162200 | Randox RX Daytona Plus Magnesium (MG) | JGJ | 2017-04-28 | 266 |
| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP) | CJE | 2017-04-21 | 252 |
| K161691 | Direct LDL Cholesterol (LDL) | MRR | 2017-03-20 | 273 |
| K152085 | Liquid CO2-2 (LCO2-2) | KHS | 2016-02-24 | 212 |
| K152343 | Direct Bilirubin | JFM | 2016-02-16 | 181 |
123 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN240035 | De Novo | Non-Factor Replacement Product Test System | 2025-05-22 |
Recalls
92 product recalls in 61 recall events; 37 initiated in the last five years. Most recent: 2024-12-20.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Randox Laboratories, Ltd. (a text match, not an official crosswalk):
- J0702 — Injection, betamethasone acetate 3 mg and betamethasone sodium phosphate 3 mg (via CEI)
- J7193 — Factor ix (antihemophilic factor, purified, non-recombinant) per i.u. (via SES)
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:
- Randox Laboratories, Ltd. (116)
- Randox Laboratories Limited (18)
Frequently asked questions
How many FDA 510(k) clearances are listed under Randox Laboratories, Ltd.?
FDA lists 133 510(k) clearances under 2 spellings of the applicant name “Randox Laboratories, Ltd.” (first 1992, latest 2026), plus 1 De Novo decision, across 77 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 Randox Laboratories, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Randox Laboratories, Ltd. is 124 days. Since 2017: 270 days, versus 169 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Randox Laboratories, Ltd.?
The most frequent FDA product codes under this applicant name are JJY (Multi-Analyte Controls, All Kinds (Assayed), 15); DJG (Enzyme Immunoassay, Opiates, 5); JIX (Calibrator, Multi-Analyte Mixture, 5).
Next steps
- See all 133 Randox Laboratories, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JJY, Randox Laboratories, Ltd.'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.