Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nemoto Kyorindo Co., Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
182 daysmedian FDA review time
403 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242212 | Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) | Nemoto Kyorindo Co., Ltd. | 2024-08-27 | 29 | 0 |
| K173450 | PRESS DUO elite, PRESS DUO elite AG | Nemoto Kyorindo Co., Ltd. | 2018-02-07 | 93 | 0 |
| K133189 | DUAL SHOT ALPHA 7 | Nemoto Kyorindo Co., Ltd. | 2014-06-30 | 256 | 0 |
| K092896 | REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS | Nemoto Kyorindo Co., Ltd. | 2010-10-29 | 403 | 0 |
| K091734 | SONIC SHOT GX | Nemoto Kyorindo Co., Ltd. | 2010-05-21 | 344 | 0 |
| K071691 | DUAL SHOT ALPHA | Nemoto Kyorindo Co., Ltd. | 2007-12-19 | 182 | 0 |
| K062168 | CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA | Nemoto Kyorindo Co., Ltd. | 2006-08-18 | 18 | 0 |
| K052633 | DUAL SHOT - CONTRAST DELIVERY SYSTEM | Nemoto Kyorindo Co., Ltd. | 2005-10-17 | 21 | 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