Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HLZ — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
92 daysmedian FDA review time
364 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253586 | RM Electrode (RMH 25-01) | Retmap, Inc. | 2026-04-01 | 135 | 0 |
| K232273 | RM Electrode (RMH 23-01) | Retmap, Inc. | 2023-12-07 | 129 | 0 |
| K961805 | TOMEY DTL ELECTRODE | Tomey Corporation USA | 1997-05-09 | 364 | 0 |
| K926540 | SOPHER AND BIERER OVUM FORCEPS | Thomasville Medical Assoc. | 1994-02-25 | 422 | 0 |
| K913239 | GOLDLENS(TM) | Doran Instruments, Inc. | 1992-01-31 | 193 | 0 |
| K844409 | DTL ELECTRODE | Sauquoit Industries, Inc. | 1985-02-14 | 92 | 0 |
| K830557 | ERG-JET ELECTRODE | Universo S.A. | 1983-03-31 | 36 | 0 |
| K820254 | GOLD FOIL ERG ELECTRODES | Cadwell Laboratories, Inc. | 1982-04-09 | 67 | 0 |
| K813399 | ERG-JET ELECTRODE | Nicolet Biomedical Instruments | 1982-01-22 | 49 | 0 |
| K781476 | MULAR GOLD LEAF ELECTRODE MODEL 7501 | Life-Tech Instruments, Inc. | 1978-11-15 | 79 | 0 |
| K760199 | ELECTRORETINOGRAPH | Lkc Technologies, Inc. | 1976-08-04 | 28 | 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