Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
HEI · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012003 | DRG REACTION CHAMBER/SAFETY TIP | Doctor'S Research Group, Inc. | 2002-02-12 | 230 | 0 |
| K920985 | SNOWDEN-PENCER IRRIGATION PUMP | Snowden-Pencer | 1992-06-09 | 99 | 0 |
| K910982 | INNERVISION IRRIGATION PUMP | M.D. Engineering, Inc. | 1991-08-26 | 172 | 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