Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HRH — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
40 daysmedian FDA review time
108 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022843 | GAYHEART CORNEAL EXCISION DEVICE | Stephens Instruments | 2002-11-01 | 66 | 0 |
| K931792 | ARTHROSCOPE | Intramed Laboratories, Inc. | 1994-06-13 | 427 | 0 |
| K873918 | HEAD & CHIN RESTS | Richmond Products, Inc. | 1987-10-28 | 34 | 0 |
| K864520 | BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON | Precision Instruments, Inc. | 1987-01-20 | 64 | 0 |
| K862524 | DEKNATEL (R) TREPHINE | Deknatel, Inc. | 1986-08-11 | 40 | 0 |
| K861825 | CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE | Storz Instrument Co. | 1986-06-09 | 28 | 0 |
| K860648 | BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA | Precision Instruments, Inc. | 1986-03-25 | 33 | 0 |
| K843646 | STEINWAY MICRO-KERATO-TREPHINE | Steinway Instrument Co., Inc. | 1985-01-03 | 108 | 0 |
| K843048 | RING SUPPORTED TREPHINE FOR CORNEA TRANS | Precision Instruments, Inc. | 1984-10-05 | 63 | 0 |
| K812723 | PEARCE CORNEAL TREPHINE | Visitec Co. | 1981-10-13 | 15 | 0 |
| K781411 | CORNEAL CUTTER AND ACCESSORIES | Codman & Shurtleff, Inc. | 1978-09-20 | 36 | 0 |
| K771866 | TROUTMAN CORNEAL PUNCH | Edward Weck, Inc. | 1977-11-09 | 37 | 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