Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HKS — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
49 daysmedian FDA review time
150 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140368 | FAMILY OF DISPOSABLE LENSES | Sensor Medical Technology, LLC | 2014-04-29 | 74 | 0 |
| K935302 | OSHER SURGICAL GONIO/POSTERIOR POLE LENS | Ocular Instruments, Inc. | 1994-04-01 | 150 | 0 |
| K895846 | TWO MIRROR GONIO LENS | Ocular Instruments, Inc. | 1989-12-18 | 76 | 0 |
| K890977 | MCINTYRE SURGICAL GONIOLENS | Ocular Instruments, Inc. | 1989-05-23 | 85 | 0 |
| K862713 | ABRAHAM IRIDECTOMY LENS (YAG LASER) | Ocular Instruments, Inc. | 1986-08-21 | 36 | 0 |
| K862692 | KARICKHOFF DIAGNOSTIC/LASER LENS | Ocular Instruments, Inc. | 1986-08-21 | 37 | 0 |
| K862512 | RITCH TRABECULOPLASTY LASER LENS | Ocular Instruments, Inc. | 1986-07-11 | 10 | 0 |
| K862024 | SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM | Ocular Instruments, Inc. | 1986-07-11 | 44 | 0 |
| K861027 | KETA HAND-HELD TONOMETER | Keta Corp. | 1986-05-06 | 49 | 0 |
| K830169 | DORC ADJUSTABLE IMAGE CONTACTS | Jedmed Instrument Co. | 1983-02-07 | 20 | 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