Tosoh Bioscience, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Tosoh Bioscience, Inc.” (first 2007, latest 2025), plus 1 PMA decision, across 13 product codes in 3 review panels. Median 510(k) review time under this name: 200 days. Since 2017 the median was 266 days, against 202 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 | 1 | 22 |
| 2013 | 1 | 127 |
| 2014 | 4 | 30 |
| 2015 | 3 | 248 |
| 2016 | 1 | 29 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 343 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 266 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tosoh Bioscience, Inc. took a median 266 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 202 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JIT | Calibrator, Secondary | 5 | 5 |
| PDJ | Hemoglobin A1c Test System | 3 | 3 |
| LCP | Assay, Glycosylated Hemoglobin | 2 | 2 |
| MRG | System, Test, Vitamin D | 2 | 2 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | 1 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 1 | 1 |
| CGN | Acid, Folic, Radioimmunoassay | 1 | 1 |
| CKG | Radioimmunoassay, Acth | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
| LPS | Urinary Homocystine (Nonquantitative) Test System | 1 | 1 |
Plus 3 more product codes.
Review panels
- Clinical Chemistry (18)
- Hematology (2)
- Immunology (1)
Most recent Tosoh Bioscience, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | PDJ | 2025-10-03 | 266 |
| K211199 | ST AIA-PACK BNP Assay | NBC | 2021-11-08 | 200 |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 | PDJ | 2021-08-05 | 486 |
| K160113 | ST AIA-PACK hsE2 Calibrator Set | JIT | 2016-02-17 | 29 |
| K153417 | ST AIA-PACK PROG III Calibrator Set | JIT | 2015-12-18 | 23 |
| K150270 | ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set | MRG | 2015-10-26 | 264 |
| K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set | CDZ | 2015-07-02 | 248 |
| K143296 | AIA-PACK C-Peptide Control Set | JJX | 2014-12-16 | 29 |
| K143144 | ST AIA-PACK PROG II Calibrator Set | JIT | 2014-12-03 | 30 |
| K140648 | ST AIA-PACK C-PEPTIDE II CALIBRATOR SET | JIT | 2014-04-10 | 28 |
10 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P910065 | PMA | AIA-PACK PSA | 1993-07-07 |
Recalls
81 product recalls in 34 recall events; 1 initiated in the last five years. Most recent: 2026-06-12.
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.
- Tosoh Medics, Inc. (41 510(k)s)
- Tosoh Corp. (11 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tosoh Bioscience, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Tosoh Bioscience, Inc.” (first 2007, latest 2025), plus 1 PMA decision, across 13 product codes in 3 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 Tosoh Bioscience, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tosoh Bioscience, Inc. is 200 days. Since 2017: 266 days, versus 202 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Tosoh Bioscience, Inc.?
The most frequent FDA product codes under this applicant name are JIT (Calibrator, Secondary, 5); PDJ (Hemoglobin A1c Test System, 3); LCP (Assay, Glycosylated Hemoglobin, 2).
Next steps
- See all 20 Tosoh Bioscience, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JIT, Tosoh Bioscience, 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, 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.