R&D Systems, Inc.: FDA clearances and approvals
R&D Systems, Inc. has 79 FDA 510(k) clearances (first 1978, latest 2016), across 22 product codes in 7 review panels. Median 510(k) review time: 50 days. openFDA lists 7 product recalls by a recalling firm named R&D Systems, Inc.
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 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 R&D Systems, Inc. have?
R&D Systems, Inc. has 79 FDA 510(k) clearances (first 1978, latest 2016), across 22 product codes in 7 review panels.
How long does FDA take to clear R&D Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across R&D Systems, Inc.'s cleared 510(k)s is 50 days.
What devices does R&D Systems, Inc. make?
Its most frequent FDA product codes are JPK (Mixture, Hematology Quality Control, 45); KRX (Calibrator For Cell Indices, 4); GGM (Control, Hemoglobin, 3).
Has R&D Systems, Inc. had device recalls?
openFDA lists 7 product recalls in 7 recall events by a recalling firm whose name matches R&D Systems, Inc; the most recent began 2022-11-07. Recall firm names are matched by name, so related entities filing under other names are not included.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.