Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medisize BV — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122885 | MEDISIZE GOLD HEATER AND BOOSTER T-PIECE | Medisize BV | 2013-08-29 | 343 | 0 |
| K081536 | MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED | Medisize BV | 2009-01-23 | 235 | 0 |
| K070714 | MEDISIZE GOLD HEATER AND BOOSTER | Medisize BV | 2007-04-30 | 47 | 0 |
| K052615 | MEDISIZE GOLD | Medisize BV | 2005-12-09 | 77 | 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