Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HQE — Predicate Candidate Screening
149 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
210 days90th percentile
149clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212763 | UniVit HE, UniVit UHS | Visioncare Devices, LLC | 2022-08-10 | 344 | 0 |
| K170183 | Cetus system, Cetus probe | A.R.C Laser GmbH | 2017-09-27 | 247 | 0 |
| K153168 | Bi-Blade Vitrectomy Cutter | Medical Instrument Development Laboratories | 2016-04-29 | 179 | 0 |
| K141065 | CONSTELLATION VISION SYSTEM | Alcon Research, Ltd. | 2014-08-22 | 120 | 6 |
| K121675 | VERSAVIT | Synergetics, Inc. | 2012-06-21 | 15 | 4 |
| K120170 | PROCARE PLUS VITRECTOMY SYSTEM | Visioncare Devices, Inc. | 2012-05-30 | 132 | 0 |
| K102222 | ULTIMATE VIT ENHAMCER (UVE) | Medical Instrument Development Laboratories, Inc. | 2011-04-08 | 245 | 0 |
| K033390 | COLIBRI DISPOSABLE VITRECTOMY CUTTER | Microworld Medical Instruments, Inc. | 2003-11-04 | 12 | 0 |
| K030948 | VMATE MODEL VMM1000 | Howard Instruments, Inc. | 2003-06-17 | 83 | 0 |
| K023939 | VELOCITY ADVANTAGE | Visioncare Devices, Inc. | 2003-04-17 | 142 | 0 |
| K020911 | MID LABS AUTONOMOUS VIT ENHANCER (AVE) | Medical Instrument Development Laboratories, Inc. | 2002-04-29 | 40 | 0 |
| K010082 | D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM | Dutch Ophthalmic USA, Inc. | 2001-03-12 | 61 | 0 |
| K992943 | VIT ENHANCER | Medical Instrument Development Laboratories, Inc. | 1999-12-10 | 101 | 0 |
| K990292 | I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, | Ophthalmic Consultants, Inc. | 1999-11-19 | 294 | 0 |
| K983797 | D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM | Dutch Ophthalmic USA, Inc. | 1999-03-03 | 126 | 0 |
| K980400 | PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10 | Peregrine Surgical , Ltd. | 1998-04-30 | 87 | 0 |
| K980399 | PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20 | Peregrine Surgical , Ltd. | 1998-04-30 | 87 | 0 |
| K980488 | STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY S | Storz Instrument Co. | 1998-03-23 | 42 | 4 |
| K970670 | REUSABLE VITRECTOMY PROBE | Altex Vision | 1997-05-06 | 71 | 0 |
| K970673 | DISPOSABLE VITRECTOMY PROBE | Altex Vision | 1997-05-05 | 70 | 0 |
| K964743 | STORZ E8010 ERGOTEC/PREMIERE ADAPTOR | Storz Instrument Co. | 1997-02-03 | 69 | 0 |
| K961738 | VIT COMMANDER SYSTEM | Scieran Technologies, Inc. | 1996-11-25 | 206 | 0 |
| K960061 | STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSOR | Storz Instrument Co. | 1996-09-18 | 258 | 0 |
| K961078 | AUTOMATED VITRECTOMY DEVICE | Promex, Inc. | 1996-06-14 | 88 | 0 |
| K954816 | STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BA | Storz Instrument Co. | 1996-03-04 | 136 | 0 |
| K953575 | STORZ MVS-3201 VITRECTOMY PROBE PACK | Storz Instrument Co. | 1995-09-14 | 45 | 0 |
| K953576 | STORZ DP4505 VITREOUS MEMBRANE DISSECTOR | Storz Instrument Co. | 1995-09-14 | 45 | 0 |
| K950852 | CUTTER, VITREOUS ANTERIOR VITRECTOMY PROBE (AVP) | H.S. Intl. Co., Inc. | 1995-05-19 | 81 | 0 |
| K950799 | PRO-VIT | M. Imonti and Associates Inc., | 1995-04-28 | 66 | 0 |
| K946135 | INFINITECH ASPIRATING LASER PROBE | Surgical Technologies, Inc. | 1995-04-18 | 123 | 0 |
| K946181 | INFINITECH SOFT TIP FLUTE NEEDLE | Surgical Technologies, Inc. | 1995-03-14 | 84 | 0 |
| K934600 | MICRODRIVE | Medical Instrument Development Laboratories, Inc. | 1994-07-27 | 306 | 0 |
| K936302 | NIDEK MODEL VT-4000, MODIFICATION | Nidek, Inc. | 1994-07-15 | 198 | 0 |
| K940391 | PEREGRINE REVERSE CUTTING KNIFE LIGHT PIPE | Peregrine Surgical , Ltd. | 1994-06-08 | 133 | 0 |
| K940746 | VIT CUTTER MODEL 94 | Visioncare Devices, Inc. | 1994-06-06 | 108 | 0 |
| K932669 | SUPRA-VIT(TM) | Medical Instrument Development Laboratories, Inc. | 1994-06-03 | 366 | 0 |
| K930842 | THE GRIESHABER SYST/AI TUBING SET AND CARTRIDGE | Grieshaber & Co. | 1994-05-03 | 440 | 0 |
| K933907 | STORZ FIBEROPTIC PICK MANIPULATOR | Storz Instrument Co. | 1994-03-07 | 208 | 0 |
| K932668 | OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER | Synergetics, Inc. | 1994-02-23 | 266 | 0 |
| K934204 | INTERTIP INFUSION SET | Oasis Medical, Inc. | 1994-02-07 | 161 | 0 |
| K933984 | STORZ FIBEROPTIC REVERSE CUTTING KNIFE | Storz Instrument Co. | 1994-01-25 | 162 | 0 |
| K933208 | BARE-FIBER ENDOILLUMINATOR | Surgical Technologies, Inc. | 1993-12-14 | 166 | 0 |
| K924353 | NIDEK MODEL VST-4000 | Nidek, Inc. | 1993-03-29 | 213 | 0 |
| K924222 | MID LABS, INC. VIT MATE | Medical Instrument Development Laboratories, Inc. | 1993-01-27 | 159 | 0 |
| K924604 | STORZ REUS 20/25 GAUGE VITRE CUT W/REUS HAND/DRIV | Storz Instrument Co. | 1992-11-27 | 77 | 0 |
| K922355 | POLLY'S VITREOUS SCISSORS J-225-S | O.R. Specialties, Inc. | 1992-08-18 | 91 | 0 |
| K921758 | STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM | Storz Instrument Co. | 1992-07-16 | 94 | 0 |
| K921460 | STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS | Storz Instrument Co. | 1992-07-02 | 97 | 0 |
| K920718 | DISPOSABLE POSTERIOR MICROSCISSORS | Storz Instrument Co. | 1992-05-18 | 90 | 0 |
| K920582 | 180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT. | Site Microsurgical Systems, Inc. | 1992-05-08 | 88 | 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