Sekisui Diagnostics P.E.I., Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Sekisui Diagnostics P.E.I., Inc.” (first 2011, latest 2022), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 242 days. Since 2017 the median was 299 days, against 160 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 35 |
| 2017 | 0 | — |
| 2018 | 1 | 283 |
| 2019 | 2 | 258 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 525 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sekisui Diagnostics P.E.I., Inc. took a median 299 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 160 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LDP | Colorimetry, Acetaminophen | 2 | 2 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 | 1 |
| JGJ | Photometric Method, Magnesium | 1 | 1 |
| JIT | Calibrator, Secondary | 1 | 1 |
| PDJ | Hemoglobin A1c Test System | 1 | 1 |
Review panels
Most recent Sekisui Diagnostics P.E.I., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202644 | Acetaminophen | LDP | 2022-02-18 | 525 |
| K182702 | SEKURE Creatine Kinase Assay | CGS | 2019-04-17 | 202 |
| K180835 | SEKURE Acetaminophen L3K Assay | LDP | 2019-02-08 | 315 |
| K173206 | SEKURE HbA1c Assay | PDJ | 2018-07-12 | 283 |
| K163078 | DC-UIBC-CAL | JIT | 2016-12-08 | 35 |
| K111915 | MAGNESIUM ASSAY | JGJ | 2011-12-02 | 149 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2016-11-29.
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.
- SEKISUI Diagnostics, LLC (6 510(k)s)
- Sekisui Medical Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sekisui Diagnostics P.E.I., Inc.?
FDA lists 6 510(k) clearances under the applicant name “Sekisui Diagnostics P.E.I., Inc.” (first 2011, latest 2022), across 5 product codes in 2 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 Sekisui Diagnostics P.E.I., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sekisui Diagnostics P.E.I., Inc. is 242 days. Since 2017: 299 days, versus 160 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sekisui Diagnostics P.E.I., Inc.?
The most frequent FDA product codes under this applicant name are LDP (Colorimetry, Acetaminophen, 2); CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes, 1); JGJ (Photometric Method, Magnesium, 1).
Next steps
- See all 6 Sekisui Diagnostics P.E.I., Inc. clearances with predicates and recalls
- Run predicate analysis for product code LDP, Sekisui Diagnostics P.E.I., 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.