Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
2006 — Predicate Candidate Screening
3,217 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
70 daysmedian FDA review time
188 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062905 | NIO FUSION 4MP; MDNC 4130 | Barcoview | 2006-12-29 | 93 | 0 |
| K062787 | ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL | Phadia US, Inc. | 2006-12-29 | 102 | 0 |
| K063612 | MODIFICATION TO HEALTH BUDDY APPLIANCE | Health Hero Network, Inc. | 2006-12-29 | 25 | 0 |
| K063140 | RAINBOW ADHESIVE CO-OXIMETRY SENSORS | Masimo Corporation | 2006-12-29 | 74 | 0 |
| K063164 | VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS | Ortho-Clinical Diagnostics, Inc. | 2006-12-28 | 71 | 1 |
| K053218 | DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX | Musculoskeletal Transplant Foundation | 2006-12-28 | 406 | 0 |
| K062652 | INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY | Tanita Corporation of America | 2006-12-28 | 112 | 0 |
| K063276 | CLINITEK ADVANTUS, MODEL 1420 | Bayer Healthcare, LLC | 2006-12-28 | 59 | 0 |
| K062788 | COLLIMATOR, MODEL M-38 | Umi International | 2006-12-28 | 101 | 0 |
| K063206 | DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIB | Dade Behring, Inc. | 2006-12-28 | 66 | 2 |
| K062555 | EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G | Visgeneer, Inc. | 2006-12-27 | 119 | 0 |
| K063643 | MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THA | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2006-12-27 | 20 | 1 |
| K062355 | ENA CEM | Micerium S.P.A. | 2006-12-27 | 135 | 0 |
| K063074 | CANDELA 3630 LASER SYSTEM | Candela Corp. | 2006-12-27 | 82 | 0 |
| K063225 | METAIZEAU NAILING SYSTEM | Howmedica Osteonics Corp. | 2006-12-27 | 64 | 1 |
| K063244 | ARC SURGICAL BONE REDUCTION SCREW | Arc Surgical, LLC | 2006-12-27 | 62 | 0 |
| K063017 | AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM | Aesculap, Inc. | 2006-12-27 | 86 | 0 |
| K062115 | CARBON DIOXIDE MONITOR, MODEL OLG-2800A | Nihon Kohden America, Inc. | 2006-12-27 | 156 | 0 |
| K063009 | FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG040 | Praesidia S.R.L. | 2006-12-27 | 86 | 0 |
| K061676 | RIGIDOMETER, MODEL DIR-4U | Uroan 21 | 2006-12-27 | 196 | 0 |
| K063262 | AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC S | Virtual Imaging | 2006-12-26 | 57 | 0 |
| K063628 | CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HA | Ge Healthcare Integrated IT Solutions | 2006-12-26 | 20 | 3 |
| K063459 | CRANEX NOVUS | Soredex Palodex Group OY | 2006-12-26 | 41 | 0 |
| K060416 | OBELISC VERTEBRAL BODY REPLACEMENT DEVICE | Ulrich GmbH & Co. KG | 2006-12-26 | 312 | 0 |
| K062583 | ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL | Phadia US, Inc. | 2006-12-26 | 116 | 0 |
| K062924 | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK | Dade Behring, Inc. | 2006-12-26 | 89 | 1 |
| K061578 | SSP VERTEBRAL BODY REPLACEMENT | Specialty Spine Products, LLC | 2006-12-26 | 202 | 0 |
| K063613 | MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE | Terumo Medical Corp. | 2006-12-26 | 21 | 0 |
| K060852 | MOONCUP | Mooncup Limited | 2006-12-26 | 273 | 0 |
| K062785 | LTD POLYAXIAL FIXATION SYSTEM | Us Spine | 2006-12-26 | 99 | 0 |
| K063143 | VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AN | Ortho-Clinical Diagnostics, Inc. | 2006-12-26 | 71 | 0 |
| K063382 | HDR CT COMPATIBLE SPLIT RING APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | 2006-12-26 | 48 | 0 |
| K062265 | CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM | Swiss Medical Care S.A. | 2006-12-26 | 144 | 0 |
| K062314 | HORUS LASER KERATOME | Carl Zeiss Meditec, AG | 2006-12-22 | 136 | 0 |
| K062661 | AEQUALIS RESURFACING HEAD | Tornier | 2006-12-22 | 106 | 0 |
| K063551 | AEQUALIS HUMERAL PLATE | Tornier | 2006-12-22 | 28 | 0 |
| K063543 | COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN T | Roche Diagnostics Corp. | 2006-12-22 | 28 | 0 |
| K063474 | ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14) | Imc-Heart Way LLC | 2006-12-22 | 36 | 0 |
| K061350 | LITHODIAMOND ULTRA | Pck Electronic Industry & Trade Co., Ltd. | 2006-12-22 | 221 | 0 |
| K062965 | CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GL | Kossan Latex Industries(M)Sdn Bhd | 2006-12-22 | 84 | 0 |
| K060346 | ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM | Ultrazonix Dnt AB | 2006-12-22 | 315 | 0 |
| K062285 | VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, F | Ortho-Clinical Diagnostics, Inc. | 2006-12-22 | 137 | 0 |
| K063166 | I.T.S. PELVIC RECONSTRUCTION SYSTEM | I.T.S. Implantat-Technologie-Systeme GmbH | 2006-12-22 | 65 | 1 |
| K063057 | IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP | Diagnostic Products Corporation | 2006-12-22 | 78 | 0 |
| K063395 | O&P BIVALVE CRANIAL MOLDING HELMET | Orthotic & Prosthetic Lab, Inc. | 2006-12-22 | 43 | 0 |
| K063484 | PATIENT DATA HANDLER & DEVICES (PDH&D) | Intermed Advisors, Inc. | 2006-12-22 | 35 | 0 |
| K062513 | APEX SPINE SYSTEM | Spinecraft, Inc. | 2006-12-22 | 116 | 0 |
| K062517 | ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES | Olympus Medical Systems Corporation | 2006-12-22 | 116 | 0 |
| K062940 | BONE INJECTION GUN (B.I.G.) | Waismed, Ltd. | 2006-12-22 | 85 | 0 |
| K063224 | GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL | Gentris Corporation | 2006-12-22 | 59 | 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