Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HJM — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
120 daysmedian FDA review time
437 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972506 | INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR | Infinitech, Inc. | 1997-10-01 | 90 | 0 |
| K950529 | PEREGRINE DIFFUSION LIGHT PIPE | Peregrine Surgical , Ltd. | 1995-06-07 | 120 | 0 |
| K945877 | WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT | Wells Johnson Co. | 1995-03-02 | 91 | 0 |
| K931072 | HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE | Hgm, Inc. | 1994-11-10 | 618 | 0 |
| K933445 | DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS) | Storz Instrument Co. | 1994-09-23 | 437 | 0 |
| K940393 | PEREGRINE WIDE ANGLE LIGHT PIPE | Peregrine Surgical , Ltd. | 1994-09-02 | 219 | 1 |
| K934269 | FIBEROPTIC ILLUMINATED INSTRUMENTS | Visitec Co. | 1994-05-17 | 259 | 0 |
| K913273 | DROLITE(TM) LIGHT SOURCE | Vision Medical, Inc. | 1991-12-04 | 134 | 0 |
| K894513 | DIATHRON(R) DIATHERMY UNIT | Intl. Ophthalmic Industries Corp. | 1989-10-31 | 104 | 0 |
| K893170 | VISTA FINOFF TRANSILLUMINATOR (AC-POWERED) | Keeler Instruments, Inc. | 1989-06-05 | 41 | 0 |
| K812949 | RMI TRANSILLUMINATOR, MODEL 292 | Radiation Measurements, Inc. | 1981-12-02 | 42 | 0 |
| K811108 | RMI TRANSILLUMINATION LIGHT METER #295 | Radiation Measurements, Inc. | 1981-07-01 | 69 | 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