R&D Systems, Inc.: FDA filings under this applicant name
FDA lists 79 510(k) clearances under the applicant name “R&D Systems, Inc.” (first 1978, latest 2016), across 22 product codes in 7 review panels. Median 510(k) review time under this name: 50 days. 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 | 0 | — |
| 2013 | 1 | 107 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 183 |
| 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 |
|---|---|---|---|
| JPK | Mixture, Hematology Quality Control | 45 | 45 |
| KRX | Calibrator For Cell Indices | 4 | 4 |
| GGM | Control, Hemoglobin | 3 | 3 |
| GGT | Assay, Erythropoietin | 3 | 3 |
| JCN | Control, Cell Counter, Normal And Abnormal | 3 | 3 |
| KSA | Calibrator For Red-Cell And White-Cell Counting | 3 | 3 |
| GKZ | Counter, Differential Cell | 2 | 2 |
| KQC | Stains, Hematology | 2 | 2 |
| FRZ | Device, Patient Transfer, Powered | 1 | 1 |
| GIF | Diluent, Blood Cell | 1 | 1 |
Plus 12 more product codes.
Review panels
- Hematology (70)
- Pathology (3)
- Immunology (2)
- Clinical Chemistry (1)
- General Hospital (1)
- Microbiology (1)
- Physical Medicine (1)
Most recent R&D Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160606 | BC-5D Hematology Control | JPK | 2016-09-01 | 183 |
| K130962 | R&D 5D RETIC HEMATOLOGY CONTROL | JPK | 2013-07-24 | 107 |
| K101578 | R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL | JPK | 2011-04-28 | 325 |
| K100050 | R & D SYSTEMS XERET HEMATOLOGY CONTROL | JPK | 2010-01-29 | 21 |
| K091433 | R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL | JPK | 2009-10-28 | 168 |
| K073178 | HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 | JPK | 2007-12-27 | 44 |
| K072846 | CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 | JPK | 2007-11-26 | 53 |
| K072268 | HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S | JPK | 2007-11-20 | 97 |
| K072096 | CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 | JPK | 2007-08-20 | 20 |
| K070334 | R&D SICKLE QC CONTROL | GGM | 2007-03-29 | 52 |
69 earlier clearances. See the full list in Caduvo.
Recalls
7 product recalls in 7 recall events; 2 initiated in the last five years. Most recent: 2022-11-07.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under R&D Systems, Inc.?
FDA lists 79 510(k) clearances under the applicant name “R&D Systems, Inc.” (first 1978, latest 2016), across 22 product codes in 7 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 R&D Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name R&D Systems, Inc. is 50 days.
Which FDA product codes appear under R&D Systems, Inc.?
The most frequent FDA product codes under this applicant name are JPK (Mixture, Hematology Quality Control, 45); KRX (Calibrator For Cell Indices, 4); GGM (Control, Hemoglobin, 3).
Next steps
- See all 79 R&D Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JPK, R&D Systems, 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.