Radiometer America, Inc.: FDA filings under this applicant name
FDA lists 50 510(k) clearances under the applicant name “Radiometer America, Inc.” (first 1983, latest 2016), across 21 product codes in 6 review panels. Median 510(k) review time under this name: 96 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Danaher (Beckman Coulter, Leica Biosystems, Radiometer, Cepheid), based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 35 |
| 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 |
|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 15 | 15 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 9 | 9 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 5 | 5 |
| DQA | Oximeter | 2 | 2 |
| JGS | Electrode, Ion Specific, Sodium | 2 | 2 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 | 2 |
| CBT | Arterial Blood Sampling Kit | 1 | 1 |
| CEM | Electrode, Ion Specific, Potassium | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| GHS | Assay, Carboxyhemoglobin | 1 | 1 |
Plus 11 more product codes.
Review panels
- Clinical Chemistry (33)
- Microbiology (9)
- Anesthesiology (4)
- Hematology (2)
- General Hospital (1)
- Clinical Toxicology (1)
Most recent Radiometer America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit | JJY | 2016-01-28 | 35 |
| K992859 | ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE | CHL | 2000-01-10 | 138 |
| K991417 | ABL 735 ANALYZER | CHL | 1999-11-24 | 215 |
| K982928 | NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM | CHL | 1999-01-06 | 139 |
| K980130 | ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM | CHL | 1998-02-09 | 26 |
| K980135 | QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 | JJS | 1998-01-28 | 13 |
| K974818 | ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM | MMI | 1998-01-16 | 24 |
| K973367 | ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM | CHL | 1997-10-06 | 28 |
| K962158 | PICO MODELS 30, 50, 70 | JKA | 1996-10-29 | 147 |
| K962334 | EML105 ELECTROLYTE METABOLITE ANALYZER | JGS | 1996-10-24 | 129 |
40 earlier clearances. See the full list in Caduvo.
Recalls
64 product recalls in 55 recall events; 0 initiated in the last five years. Most recent: 2019-07-10.
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.
- Radiometer Medical Aps (28 510(k)s)
- Radiometer Medicals Aps (5 510(k)s)
- Radiometer Medical A/S (2 510(k)s)
- Radiometer Basel AG (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Radiometer America, Inc.?
FDA lists 50 510(k) clearances under the applicant name “Radiometer America, Inc.” (first 1983, latest 2016), across 21 product codes in 6 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 Radiometer America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Radiometer America, Inc. is 96 days.
Which FDA product codes appear under Radiometer America, Inc.?
The most frequent FDA product codes under this applicant name are CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, 15); JJS (Controls For Blood-Gases, (Assayed And Unassayed), 9); JWY (Manual Antimicrobial Susceptibility Test Systems, 5).
Next steps
- See all 50 Radiometer America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CHL, Radiometer America, 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.