Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shanghai Draeger Medical Instrument Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250349 | Vista CMS | Shanghai Draeger Medical Instrument Co., Ltd. | 2026-04-24 | 441 | 0 |
| K252250 | Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (260106 | Shanghai Draeger Medical Instrument Co., Ltd. | 2026-04-10 | 267 | 0 |
| K251669 | IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP trans | Shanghai Draeger Medical Instrument Co., Ltd. | 2025-09-30 | 123 | 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