Randox Laboratories, Ltd.: FDA filings under this applicant name
FDA lists 115 510(k) clearances under the applicant name “Randox Laboratories, Ltd.” (first 1992, latest 2023), plus 1 De Novo decision, across 75 product codes in 4 review panels. Median 510(k) review time under this name: 108 days. Since 2017 the median was 161 days, against 186 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 | 5 | 139 |
| 2013 | 5 | 31 |
| 2014 | 1 | 224 |
| 2015 | 1 | 200 |
| 2016 | 2 | 127 |
| 2017 | 1 | 266 |
| 2018 | 1 | 85 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 161 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Randox Laboratories, Ltd. took a median 161 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 186 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 9 | 9 |
| 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 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 3 | 3 |
| CEM | Electrode, Ion Specific, Potassium | 2 | 2 |
| CGA | Glucose Oxidase, Glucose | 2 | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 | 2 |
Plus 65 more product codes.
Review panels
- Clinical Chemistry (66)
- Clinical Toxicology (30)
- Immunology (16)
- Hematology (4)
Most recent Randox Laboratories, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| 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 |
| K152085 | Liquid CO2-2 (LCO2-2) | KHS | 2016-02-24 | 212 |
| K153435 | Direct HDL Cholesterol (HDL) | LBS | 2016-01-08 | 42 |
| K150654 | Cholesterol | CHH | 2015-09-29 | 200 |
| K131554 | RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT | JJE | 2014-01-09 | 224 |
| K123977 | RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR | CGS | 2013-11-21 | 330 |
| K132156 | RANDOX CSF CONTROLS LEVELS 2 AND 3 | JJY | 2013-10-23 | 104 |
| K132090 | BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2 | DLJ | 2013-08-08 | 27 |
105 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
85 product recalls in 57 recall events; 36 initiated in the last five years. Most recent: 2024-06-07.
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)
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.
- Randox Laboratories Limited (18 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Randox Laboratories, Ltd.?
FDA lists 115 510(k) clearances under the applicant name “Randox Laboratories, Ltd.” (first 1992, latest 2023), plus 1 De Novo decision, across 75 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 108 days. Since 2017: 161 days, versus 186 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), 9); JIX (Calibrator, Multi-Analyte Mixture, 5); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 5).
Next steps
- See all 115 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, 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.