Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Linear Health Sciences, LLC — 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) |
|---|---|---|---|---|---|
| K241415 | Orchid Safety Release Valve™ | Linear Health Sciences, LLC | 2024-09-06 | 112 | 0 |
| K232094 | Orchid Safety Release ValveTM | Linear Health Sciences, LLC | 2023-10-03 | 82 | 0 |
| K230266 | Orchid Safety Release Valve | Linear Health Sciences, LLC | 2023-05-04 | 93 | 0 |
| K212064 | Orchid Safety Release Valve(TM) | Linear Health Sciences, LLC | 2022-05-03 | 305 | 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