Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
2018 — Predicate Candidate Screening
3,062 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
117 daysmedian FDA review time
282 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K183101 | Zenition 50 | Philips Medical Systems Nederland B.V. | 2018-12-31 | 54 | 4 |
| K183000 | ViperCath XC Peripheral Exchange Catheter | Cardiovascular Systems, Inc. | 2018-12-29 | 60 | 0 |
| K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic A | Institut Straumann AG | 2018-12-28 | 184 | 0 |
| DEN170091 | EyeBOX | Oculogica, Inc. | 2018-12-28 | 371 | 0 |
| K182736 | OIC Suture Anchor System | The Orthopaedic Implant Company | 2018-12-28 | 91 | 0 |
| K180867 | AmCAD-UO | Amcad Biomed Corporation | 2018-12-28 | 270 | 0 |
| K180204 | CranioMaxillofacial Fixation (CMF) System - CMF Visionare | Visionare, LLC | 2018-12-28 | 338 | 0 |
| K183369 | COR12 ECG | Corscience GmbH & Co. | 2018-12-28 | 24 | 0 |
| K182045 | Lotus III Multi-Pulsed Er: Yag Laser System | Laseroptek Co., Ltd. | 2018-12-27 | 150 | 0 |
| K182404 | STERRAD VELOCITY Biological Indicator | Advanced Sterilization Products (Asp) | 2018-12-27 | 114 | 0 |
| K182845 | minisono | Alpinion Medical Systems Co., Ltd. | 2018-12-27 | 79 | 0 |
| K182564 | Quantib ND | Quantib B.V. | 2018-12-27 | 100 | 0 |
| K182461 | LATITUDE EV Total Elbow Arthroplasty | Tornier, Inc. | 2018-12-27 | 108 | 0 |
| K182130 | iSchemaView RAPID | Ischemaview, Inc. | 2018-12-27 | 143 | 0 |
| K183169 | Pulse 2.0, Pulse Pro 2.0 | NormaTec Industries, LP | 2018-12-27 | 41 | 0 |
| K181761 | Zimmer Biomet Select Ceramic Heads | Zimmer, Inc. | 2018-12-26 | 176 | 0 |
| K182698 | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAI | DiaSorin, Inc. | 2018-12-26 | 90 | 0 |
| K182783 | DePuy Synthes Trauma Orthopedic Nail Implants | DePuy Synthes | 2018-12-26 | 86 | 0 |
| K182099 | Delta TT Pro | Lima Corporate S.P.A. | 2018-12-26 | 145 | 0 |
| K182242 | VO200 – NeurOs Cerebral Oximetry System | Mespere Lifesciences, Inc. | 2018-12-26 | 128 | 0 |
| K182709 | One-Step Suprapubic Introducer | Cook Incorporated | 2018-12-26 | 90 | 0 |
| K181641 | QuikClot Radial | Z-Medica, LLC | 2018-12-24 | 186 | 0 |
| K183007 | EliA SmDP Immunoassay | Phadia AB | 2018-12-24 | 54 | 0 |
| K181555 | Arthrex Fracture Adapter Hemi Shoulder Prosthesis | Arthrex, Inc. | 2018-12-21 | 191 | 0 |
| K181412 | VITEK MS | bioMerieux, Inc. | 2018-12-21 | 205 | 0 |
| K180380 | vital signs monitor | Edan Instruments, Inc. | 2018-12-21 | 312 | 1 |
| K182755 | Disposable Temperature Probe | Shenzhen Caremed Medical Technology Co., Ltd. | 2018-12-21 | 84 | 0 |
| DEN180007 | Miris Human Milk Analyzer | Miris AB | 2018-12-21 | 312 | 0 |
| K181331 | JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oy | Juvora, Ltd. | 2018-12-21 | 214 | 0 |
| K182795 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018-12-21 | 81 | 0 |
| K182012 | ADVIA Centaur Calcitonin (CALCT) assay | Axis-Shield Diagnostics Limited | 2018-12-21 | 147 | 0 |
| K182690 | ePlex Blood Culture Identification Panel Fungal Pathogen (BC | Genmark Diagnostics, Incorporated | 2018-12-21 | 85 | 0 |
| K182032 | SterilContainer S System | Aesculap, Inc. | 2018-12-21 | 144 | 0 |
| K180826 | Natrelle 133 Plus MICROCELL Tissue Expander | Allergan | 2018-12-21 | 266 | 0 |
| K180821 | TruMatch Graft Cage - Long Bone | Synthes (Usa), LLC | 2018-12-21 | 266 | 0 |
| K181752 | Stryker iVAS Elite Inflatable Vertebral Augmentation System | Stryker Corporation | 2018-12-21 | 172 | 0 |
| K183328 | Pulse Rx 2.0, Pulse Pro Rx 2.0 | NormaTec Industries, LP | 2018-12-21 | 21 | 0 |
| K182750 | 4D View | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018-12-21 | 84 | 0 |
| K183059 | 3nethra neo | Forus Health Pvt.Ltd | 2018-12-21 | 49 | 0 |
| K182781 | PTS Professional Chemistry Kit | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2018-12-21 | 81 | 0 |
| K182682 | OrthoGold 100 | Tissue Regeneration Technologies | 2018-12-21 | 86 | 0 |
| K182167 | The ICHOR Panacea Vascular Embolectomy Catheter System | Ichor Vascular, Inc. | 2018-12-21 | 133 | 0 |
| K181690 | Clear-Jet Injection Catheter | Finemedix Co., Ltd. | 2018-12-21 | 178 | 0 |
| K183012 | vascuCAP | Elucid Bioimaging, Inc. | 2018-12-21 | 51 | 0 |
| K173747 | REXLENE | Sm Eng Co., Ltd. | 2018-12-21 | 378 | 0 |
| K181037 | DIO CAD/CAM Abutment | Dio Corporation | 2018-12-21 | 246 | 0 |
| K173036 | North-vision Multi-parameter Patient Monitor | North-Vision Tech., Inc. | 2018-12-21 | 449 | 0 |
| DEN170070 | MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapa | Cytocell, Ltd. | 2018-12-21 | 448 | 0 |
| K182776 | Neocis Guidance System | Neocis, Inc. | 2018-12-21 | 81 | 0 |
| K183068 | Nitrile Glove Powder Free White | Haining Medical Products Co., Ltd. | 2018-12-21 | 46 | 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