Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HLT · 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) |
|---|---|---|---|---|---|
| K924277 | DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING | Chalgren Enterprises, Inc. | 1994-12-07 | 834 | 0 |
| K921815 | TOMEY PE-300 PORTABLE ERG | Tomey Corporation USA | 1992-07-15 | 91 | 0 |
| K841293 | PANORAMIC LOUPES - VARIOUS | Keller Instruments, Inc. | 1984-05-09 | 41 | 0 |
| K781543 | ORBIOGRAPH | Sonometrics Systems, Inc. | 1978-10-24 | 46 | 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