Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Thayer Medical Corporation · 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) |
|---|---|---|---|---|---|
| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Sp | Thayer Medical Corporation | 2024-06-18 | 225 | 0 |
| K210558 | LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber | Thayer Medical Corporation | 2022-04-01 | 400 | 0 |
| K160109 | Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding | Thayer Medical Corporation | 2017-05-19 | 486 | 0 |
| K111570 | MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR | Thayer Medical Corporation | 2011-09-29 | 115 | 1 |
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