Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Otsuka Pharmaceutical Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
142 daysmedian FDA review time
413 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092817 | POC-AS10 AUTO SAMPLER | Otsuka Pharmaceutical Co., Ltd. | 2010-03-09 | 176 | 0 |
| K052716 | RAPIRUN H. PYLORI ANTIBODY DETECTION KIT | Otsuka Pharmaceutical Co., Ltd. | 2006-11-16 | 413 | 0 |
| K041148 | POCONE INFRARED SPECTROPHOTOMETER | Otsuka Pharmaceutical Co., Ltd. | 2004-07-15 | 73 | 0 |
| K013371 | UBIT-IR300 INFRARED SPECTROMETRY SYSTEM | Otsuka Pharmaceutical Co., Ltd. | 2001-12-21 | 71 | 1 |
| K001032 | RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY | Otsuka Pharmaceutical Co., Ltd. | 2000-07-24 | 116 | 0 |
| K991083 | RLP CHOLESTEROL IMMUNOSEPARATION ASSAY | Otsuka Pharmaceutical Co., Ltd. | 1999-08-20 | 142 | 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