Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LAW — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K920223 | CHEM CHEX THEOPHYLLINE CONTROL | Streck Laboratories, Inc. | 1992-06-10 | 145 | 0 |
| K914251 | MODEL IRC PASSPORT NEBULIZER | Invacare Corp. | 1992-01-24 | 123 | 0 |
| K903924 | BIOTRACK THEOPHYLLINE QUALITY CONTROLS | Biotrack, Inc. | 1990-09-17 | 24 | 0 |
| K871589 | THEOPHYLLINE FPIA CONTROLS | Sigma Chemical Co. | 1987-06-17 | 54 | 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