Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
2017 — Predicate Candidate Screening
3,200 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
119 daysmedian FDA review time
270 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171573 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brus | Wilson-Cook Medical, Inc. | 2017-12-29 | 213 | 0 |
| K173403 | GEM Premier 5000 | Instrumentation Laboratory CO | 2017-12-29 | 59 | 0 |
| K171108 | AUTOBAHN Nailing System | Globus Medical, Inc. | 2017-12-29 | 259 | 0 |
| K171737 | Micro Touch Denta Glove Nitrile Hydrasoft Patient Examinatio | Ansell Healthcare Products, LLC | 2017-12-29 | 200 | 0 |
| K172474 | Celerity 20 HP Biological Indicator | STERIS Corporation | 2017-12-29 | 136 | 0 |
| K172357 | Disposable Powder Free Vinyl Exam Glove, Clear/Yellow | Ever Growth (Vietnam) Co. , Ltd. | 2017-12-29 | 148 | 0 |
| K173102 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | 2017-12-29 | 91 | 0 |
| K170165 | Osteo-P Bone Graft Substitute | Molecular Matrix, Inc. | 2017-12-29 | 344 | 0 |
| K173664 | Medtronic O-arm O2 Imaging System | Medtronic, Inc. | 2017-12-29 | 30 | 1 |
| K172505 | MIS C1 Narrow Platform Conical Connection Implant System, MI | Mis Implants Technologies , Ltd. | 2017-12-28 | 132 | 0 |
| DEN160037 | dermaPACE System | Sanuwave, Inc. | 2017-12-28 | 521 | 0 |
| K171061 | MRSASelect II | Bio-Rad | 2017-12-28 | 262 | 0 |
| K173087 | UroLift System (UL400 and UL500) | Neotract, Inc. | 2017-12-28 | 90 | 0 |
| K163328 | Planmed Clarity | Planmed OY | 2017-12-28 | 395 | 0 |
| K173652 | Piccolo Composite Nailing System | CarboFix Orthopedics , Ltd. | 2017-12-28 | 30 | 0 |
| K171269 | X-PSI Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2017-12-28 | 241 | 0 |
| K172848 | MEVION S250i Proton Beam Radiation Therapy Device | Mevion Medical Systems | 2017-12-27 | 99 | 0 |
| K170104 | COMPACT S, COMPACT S (LED) | Dmetec.Co., Ltd. | 2017-12-27 | 349 | 0 |
| K171037 | PoreStar Patient Specific Implant | Anatomics Pty, Ltd. | 2017-12-27 | 265 | 0 |
| K173420 | Radiomics App v1.0 | Microsoft Corp. | 2017-12-27 | 56 | 0 |
| K173073 | AltiVate Anatomic to Reverse Conversion Module | Encore Medical L.P. | 2017-12-26 | 88 | 0 |
| K172904 | IntelliVue Capnography Extension, IntelliVue Microstream Ext | Philips Medizin Systeme Boeblingen GmbH | 2017-12-26 | 95 | 0 |
| K171049 | Real Time Image Gating System for Proton Beam Therapy System | Hitachi, Ltd. Healthcare | 2017-12-26 | 263 | 0 |
| K173008 | SCS 17-01 | Anika Therapeutics, Inc. | 2017-12-26 | 90 | 0 |
| K172645 | iLux Instrument, iLux Disposable | Tear Film Innovations, Inc. | 2017-12-26 | 116 | 0 |
| K170138 | NEURONAUTE | Bioserenity | 2017-12-26 | 343 | 0 |
| K170960 | CoaguChek Vantus System | Roche Diagnostics | 2017-12-25 | 269 | 1 |
| K171584 | B. Braun Tear-Away Introducer Needle | B.Braun Medical, Inc. | 2017-12-22 | 205 | 0 |
| K172507 | SOZO | ImpediMed Limited | 2017-12-22 | 126 | 0 |
| K172785 | CONQUEST FN | Smith & Nephew | 2017-12-22 | 98 | 0 |
| K173492 | MRDx BCR-ABL Test, MRDx BCR-ABL Test Software | Molecularmd Corporation | 2017-12-22 | 39 | 0 |
| K172388 | VPOD ITPR | Advanced Circulatory System, A Wholly Owned Subsidiary OF | 2017-12-22 | 136 | 0 |
| K172383 | Arthrosurface Bone Screws | Arthrosurface, Inc. | 2017-12-22 | 136 | 0 |
| K172688 | Align Radial Head System | Skeletal Dynamics, LLC | 2017-12-22 | 107 | 0 |
| K172978 | SurgeoBite | Surgovations, LLC | 2017-12-22 | 86 | 0 |
| K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotecti | Inova Diagnostics, Inc. | 2017-12-22 | 263 | 0 |
| K172257 | TrueDX hCG Early Result Pregnancy Test (Midstream Format), T | True Diagnostics, Inc. | 2017-12-22 | 149 | 0 |
| K171581 | Neuro Omega System | Alpha Omega Engineering , Ltd. | 2017-12-22 | 205 | 1 |
| K172706 | GammaPod - Model A | Xcision Medical Systems, LLC | 2017-12-22 | 106 | 1 |
| DEN160014 | remOVE System | Ovesco Endoscopy AG | 2017-12-22 | 620 | 0 |
| K172330 | Blustone Synergy Silica System | Blustone Synergy | 2017-12-21 | 141 | 0 |
| K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Cor | Globus Medical, Inc. | 2017-12-21 | 183 | 0 |
| K172973 | Life Spine Foot and Ankle Plating System | Life Spine, Inc. | 2017-12-21 | 86 | 0 |
| K172467 | OMNI ARC Anteverted Neck Hip Stem | Omnilife Science | 2017-12-21 | 128 | 0 |
| K171043 | Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hyd | Coloplast Corp. | 2017-12-21 | 258 | 0 |
| K172623 | NuVasive Navigation Instruments | Nu Vasive, Incorporated | 2017-12-21 | 111 | 0 |
| K172560 | PREMIUM ONE Implant Systems | Sweden & Martina S.P.A. | 2017-12-21 | 118 | 0 |
| K171109 | Praxiject 0.9% NaCl | Medxl, Inc. | 2017-12-21 | 251 | 0 |
| K170028 | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone | Dako Denmark A/S | 2017-12-21 | 352 | 0 |
| K171530 | Deltaven XiV Max, Deltaven XiV Max FF | Delta Med Spa | 2017-12-21 | 210 | 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