Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HNN — Predicate Candidate Screening
54 FDA 510(k) clearances under this product code; the 50 most recent screened below.
33 daysmedian FDA review time
125 days90th percentile
54clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110166 | CLEARCUT S SAFETY KNIFE | Alcon Research, Ltd. | 2011-05-20 | 120 | 4 |
| K922378 | OPHTHALMIC KNIFE | Microptics Development Laboratory | 1992-12-10 | 204 | 0 |
| K882402 | RETRACTIVE INCISION MICROMETER (RIM) GUAGE | Optical Center | 1988-08-22 | 73 | 0 |
| K881669 | MVR/STILETTO BLADE 20GA. - P/N 1900 | Advanced Surgical Products, Inc. | 1988-05-13 | 25 | 0 |
| K874979 | PRISMA DISPOSABLE MVR/STILETTO BLADE | Advanced Surgical Products, Inc. | 1988-04-13 | 133 | 0 |
| K874057 | OPHTHALMIC TIP & BLADE SCALPELS | Myocure, Inc. | 1987-12-23 | 79 | 0 |
| K874056 | OPHTHALMIC DISPOSABLE BLADES | Myocure, Inc. | 1987-12-22 | 78 | 0 |
| K873385 | OPHTHALMIC PHACO-BLADE | Myocure, Inc. | 1987-09-21 | 28 | 0 |
| K871285 | KNIFE, OPHTHALMIC | Trueline Instruments, Inc. | 1987-04-27 | 27 | 0 |
| K864290 | RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE | Keeler Instruments, Inc. | 1986-12-15 | 45 | 0 |
| K863725 | CATARACT DIAMOND KNIFE | Medical Technology Development Corp. | 1986-10-31 | 38 | 0 |
| K863665 | THE ULTIMATE | Myocure, Inc. | 1986-09-25 | 7 | 0 |
| K861744 | SAPPHIRE KNIFE BLADE | Keeler Instruments, Inc. | 1986-06-09 | 34 | 0 |
| K861748 | RUBY & SAPPHIRE BLADE HOLDER | Keeler Instruments, Inc. | 1986-06-02 | 27 | 0 |
| K861491 | ROPHAE DIAMOND KNIFE | Rophae Lens Co., Inc. | 1986-05-28 | 36 | 0 |
| K861732 | STORZ E9050 & E9055 DIAMOND KNIVES | Storz Instrument Co. | 1986-05-28 | 22 | 0 |
| K861334 | CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE | Cilco, Inc. | 1986-05-02 | 23 | 0 |
| K860852 | SAPPHIRE BLADE SURGICAL KNIFE | Med-Tech Develoment Corp. | 1986-03-28 | 21 | 0 |
| K855050 | STORZ E9040 & E9046 DIAMOND KNIVES | Storz Instrument Co. | 1986-03-05 | 78 | 0 |
| K860332 | DIAMOND BLADE MICROMETER KNIFE | Med-Tech Develoment Corp. | 1986-02-13 | 15 | 0 |
| K860331 | DISPOSABLE SURGICAL KNIFE | Med-Tech Develoment Corp. | 1986-02-12 | 14 | 0 |
| K860305 | BEAVER MICRO-GEM GAUGE BLOCK | Rudolph Beaver, Inc. | 1986-02-12 | 15 | 0 |
| K853598 | OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE | Myocure, Inc. | 1985-11-04 | 69 | 0 |
| K852706 | VERSABLADE | Alphamedix, Inc. | 1985-11-04 | 131 | 0 |
| K852828 | BEAVER R-K KNIFE | Rudolph Beaver, Inc. | 1985-11-04 | 125 | 0 |
| K853403 | STORZ DIAMOND KNIFE | Storz Instrument Co. | 1985-11-04 | 84 | 0 |
| K853063 | SMARTKNIFE SYSTEM | CooperVision, Inc. | 1985-11-04 | 108 | 0 |
| K852633 | VERSABLADE | Alphamedix, Inc. | 1985-11-04 | 137 | 0 |
| K853499 | MICRON-SCOPE | Magnum Diamond, Inc. | 1985-09-24 | 35 | 0 |
| K853129 | BEAVER MULTIPURPOSE SAPPHIRE KNIFE | Rudolph Beaver, Inc. | 1985-08-06 | 11 | 0 |
| K851790 | 37-200 TO 37-246 VARIOUS OPHTHALMOLOGY SCALPELS/KN | Artiberia | 1985-05-23 | 28 | 0 |
| K842647 | CATARACT TRAY | Deroyal Industries, Inc. | 1985-05-09 | 303 | 0 |
| K850049 | KATENA MICROMETER KNIFE W/XTAL BLADE OF CRYSTAL SA | Xtal Corp. | 1985-03-06 | 57 | 0 |
| K844553 | MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE | Codman & Shurtleff, Inc. | 1984-12-11 | 20 | 0 |
| K843447 | CILCO DIAMOND KNIFE | Cilco, Inc. | 1984-10-05 | 30 | 0 |
| K841951 | MICROSURGICAL KNIFE | ETHICON, Inc. | 1984-06-01 | 18 | 0 |
| K840855 | CORNEAL SCLERAL LANCE | Sharpoint, Inc. | 1984-05-09 | 75 | 0 |
| K834546 | SURGICAL KNIFE | Fine-Cut Diamond Instruments | 1984-03-16 | 80 | 0 |
| K832844 | RUBY KNIVES FOR OPHTH. SURGERY | Keeler Instruments, Inc. | 1983-09-29 | 38 | 0 |
| K831975 | LEADING EDGE OPHTHALMIC KNIFE | Surgidev Corp. | 1983-08-31 | 72 | 0 |
| K831266 | MICROSURGICAL KNIFE | Vxtra Corp. | 1983-06-10 | 53 | 0 |
| K830366 | DIAMOND KNIFE | Koi, Inc. | 1983-03-09 | 33 | 0 |
| K822112 | OPHTHALMIC KNIFE | Sharpoint, Inc. | 1982-08-10 | 22 | 9 |
| K821440 | V LANCE | Sharpoint, Inc. | 1982-06-14 | 32 | 0 |
| K820618 | MICROSURGERY KNIFE | Visitec Co. | 1982-04-09 | 32 | 1 |
| K812918 | PILLING K KNIFE | Narco Scientific | 1981-11-06 | 18 | 0 |
| K812620 | ADJUSTABLE MICROSURGICAL KNIFE | Vxtra Corp. | 1981-10-19 | 34 | 0 |
| K812450 | KOI DIAMOND KNIFE | Koi, Inc. | 1981-09-21 | 24 | 0 |
| K791981 | SWAN KNIFE NEEDLE 1.5MM CAT # 1170 | Edward Weck, Inc. | 1979-10-04 | 9 | 0 |
| K791980 | TOME'S #'S 1221,1222,1223,1314,6640,6642 | Edward Weck, Inc. | 1979-10-04 | 9 | 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