Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Tosoh Bioscience, Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
200 daysmedian FDA review time
486 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | Tosoh Bioscience, Inc. | 2025-10-03 | 266 | 0 |
| K211199 | ST AIA-PACK BNP Assay | Tosoh Bioscience, Inc. | 2021-11-08 | 200 | 0 |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 | Tosoh Bioscience, Inc. | 2021-08-05 | 486 | 0 |
| K160113 | ST AIA-PACK hsE2 Calibrator Set | Tosoh Bioscience, Inc. | 2016-02-17 | 29 | 0 |
| K153417 | ST AIA-PACK PROG III Calibrator Set | Tosoh Bioscience, Inc. | 2015-12-18 | 23 | 1 |
| K150270 | ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Cal | Tosoh Bioscience, Inc. | 2015-10-26 | 264 | 0 |
| K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set | Tosoh Bioscience, Inc. | 2015-07-02 | 248 | 0 |
| K143296 | AIA-PACK C-Peptide Control Set | Tosoh Bioscience, Inc. | 2014-12-16 | 29 | 0 |
| K143144 | ST AIA-PACK PROG II Calibrator Set | Tosoh Bioscience, Inc. | 2014-12-03 | 30 | 0 |
| K140648 | ST AIA-PACK C-PEPTIDE II CALIBRATOR SET | Tosoh Bioscience, Inc. | 2014-04-10 | 28 | 0 |
| K131580 | AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 | Tosoh Bioscience, Inc. | 2014-01-23 | 237 | 0 |
| K123131 | ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CAL | Tosoh Bioscience, Inc. | 2013-02-08 | 127 | 0 |
| K121533 | ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATO | Tosoh Bioscience, Inc. | 2012-06-15 | 22 | 0 |
| K111335 | ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL | Tosoh Bioscience, Inc. | 2011-12-01 | 203 | 0 |
| K111762 | ST AIA-PACK DHEA-S CALIBRATOR SET | Tosoh Bioscience, Inc. | 2011-08-05 | 43 | 0 |
| K093960 | ST AIA-PACK CYSTATIN C, MODEL 025217 | Tosoh Bioscience, Inc. | 2010-09-14 | 265 | 0 |
| K100304 | ST AIA PACK HBA1C | Tosoh Bioscience, Inc. | 2010-08-27 | 205 | 0 |
| K091332 | AIA-PACK RBC FOLATE | Tosoh Bioscience, Inc. | 2009-10-02 | 149 | 0 |
| K071132 | G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 | Tosoh Bioscience, Inc. | 2008-09-16 | 512 | 0 |
| K063605 | ST AIA-PACK INTACT PTH ASSAY | Tosoh Bioscience, Inc. | 2007-06-21 | 199 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda