Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HRN — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
111 daysmedian FDA review time
328 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200911 | MIRA Adapter | Phakos | 2020-06-02 | 57 | 0 |
| K180195 | Frigitronics adapter | Phakos | 2018-03-16 | 51 | 0 |
| K162756 | PHAKOS Disposable Retinal Cryo Probe | Phakos | 2017-05-03 | 215 | 0 |
| K160591 | D.O.R.C. Disposable Cryo Probe | Dutch Ophthalmic Research Center International BV | 2017-01-23 | 328 | 0 |
| K131787 | CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CR | Keeler, Ltd. | 2013-12-23 | 188 | 0 |
| K112093 | CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PR | Keeler Instruments, Inc. | 2011-12-08 | 139 | 0 |
| K062412 | CRYOMATIC | Keeler Instruments, Inc. | 2006-11-06 | 81 | 0 |
| K012821 | D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM | Dutch Ophthalmic USA, Inc. | 2001-10-22 | 60 | 0 |
| K992954 | KEELER CRYO MASTER & PROBES | Keeler Instruments, Inc. | 1999-12-21 | 111 | 0 |
| K823768 | CLIRANS TE08 HOLLOW FIBER DIALYZER | Terumo Medical Corp. | 1983-01-08 | 25 | 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