Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
2015 — Predicate Candidate Screening
3,020 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
123 daysmedian FDA review time
279 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153208 | Internal Joint Stabilizer - Elbow | Skeletal Dynamics, LLC | 2015-12-31 | 56 | 0 |
| K153094 | Visions PV .035 Digital IVUS Catheter | Volcano Corporation | 2015-12-31 | 66 | 0 |
| K150585 | Ascent 3D | CAO Group, Inc. | 2015-12-31 | 297 | 0 |
| K152809 | Giraffe Incubator Carestation CS1 | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2015-12-31 | 94 | 2 |
| K152644 | KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX | Keeler Limited | 2015-12-31 | 106 | 0 |
| K152508 | Ageless Health Medical Digital Thermometer | Dongguan Ageless Health Industrial Co., Ltd. | 2015-12-31 | 120 | 0 |
| K151876 | Bio2 Fusion Implant System | Bio2 Technologies, Inc. | 2015-12-30 | 174 | 0 |
| K152201 | MedActive Oral Gel and Spray | Medactive Oral Pharmaceuticals, LLC | 2015-12-30 | 146 | 0 |
| K152586 | Beacon Fine Needle Fiducial System | Covidien, LLC | 2015-12-30 | 111 | 0 |
| K153463 | CD HORIZON Spinal System, IPC POWEREASE System | Medtronic Sofamor Danek USA, Inc. | 2015-12-30 | 29 | 0 |
| K152968 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2015-12-30 | 83 | 0 |
| K152889 | SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN P | Biorenew Labs, LLC | 2015-12-30 | 91 | 0 |
| K152373 | VITA VM LC Flow | Vita Zahnfabrik H.Rauter GmbH & Co. | 2015-12-30 | 131 | 0 |
| K151686 | HumanPen Ergo II | Eli Lilly and Company, Inc. | 2015-12-30 | 190 | 0 |
| K151907 | Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cab | Zimmer, Inc. | 2015-12-30 | 170 | 0 |
| K151255 | Navigator Aesthetic Delivery System | Carticept Medical, Inc. | 2015-12-30 | 232 | 0 |
| K151025 | iHearTest | Ihear Medical, Inc. | 2015-12-29 | 257 | 0 |
| K152860 | HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATIO | Conmed Corporation | 2015-12-29 | 90 | 0 |
| K150729 | SpectraShield 9500 Surgical N95 Respirator | Nexera Medical, Inc. | 2015-12-29 | 284 | 0 |
| K153053 | Traxcess Pro 14 Guidewire | MicroVention, Inc. | 2015-12-29 | 70 | 0 |
| K152112 | VisualEyes | Interacoustics A/S | 2015-12-29 | 153 | 0 |
| K150841 | Luvena Enhanced Personal Moisturizer, Luvena Enhanced Person | Laclede, Inc. | 2015-12-29 | 274 | 0 |
| K151762 | PediatrOS RigidTack/FlexTack | Merete Medical GmbH | 2015-12-28 | 182 | 0 |
| K152951 | Advanced Imaging Modality (AIM) Sterilization Tray, Endoscop | Paragon Medical, Inc. | 2015-12-28 | 83 | 0 |
| K153154 | Asnis JFX System | Stryker Trauma AG | 2015-12-28 | 56 | 0 |
| K153158 | Solution Administration Sets with 0.2 Micron Filter | Baxter Healthcare Corporation | 2015-12-28 | 56 | 2 |
| K151364 | Intellijoint HIP(tm) System | Intellijoint Surgical, Inc. | 2015-12-28 | 221 | 0 |
| K152162 | Myray- HYPERION X5 | Cefla S.C. | 2015-12-24 | 143 | 0 |
| K152542 | Powder Free Nitrile Examination Glove (Blue) With Low Dermat | Riverstone Resources Sdn Bhd | 2015-12-24 | 111 | 0 |
| K152283 | MAGNETOM Amira | Siemens Medical Solutions USA, Inc. | 2015-12-24 | 134 | 0 |
| K152851 | BrainPort V100 | Wicab, Inc. | 2015-12-24 | 86 | 0 |
| K153492 | CareView 1800L | Careray Digital Medical System Co., Ltd. | 2015-12-24 | 20 | 0 |
| DEN140024 | cNEP Airway | Sommetrics | 2015-12-23 | 492 | 0 |
| K152128 | 2-in-1 Abdominal Muscle Training & Back Pain Relief System | Tohkai Precision Electrical Manufactory (Shenzhen) Limited | 2015-12-23 | 145 | 0 |
| K152406 | SalivaMAX | Forward Science, LLC | 2015-12-23 | 120 | 0 |
| K153071 | Solitaire Platinum Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015-12-23 | 62 | 0 |
| K152047 | INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid | Ascension Orthopedics | 2015-12-23 | 153 | 0 |
| K150676 | L-Mesitran Dressing Family II- Soft and Tulle | Theo Manufacturing BV | 2015-12-23 | 282 | 0 |
| K142879 | BTM Wound Dressing | Polynovo Biomaterials Pty, Ltd. | 2015-12-23 | 447 | 0 |
| K151890 | Medical Diode Laser Systems | Wuhan Gigaa Optronics Technology Co., Ltd. | 2015-12-23 | 166 | 0 |
| K152330 | Expression MR400 MRI Patient Monitoring System | Invivo Corporation | 2015-12-23 | 127 | 0 |
| K151567 | ENDOPLUS hand-held laparoscopic instruments | Endoplus | 2015-12-23 | 196 | 0 |
| K152038 | MammoGRIP | Women'S Imaging Solutions Enterprises, LLC | 2015-12-22 | 153 | 0 |
| K150831 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2015-12-22 | 267 | 0 |
| K152460 | Rectangular Corpectomy Cage | Amendia, Inc. | 2015-12-22 | 116 | 0 |
| K152370 | PRECICE Trauma Nail System | Ellipse Technologies, Incorporated | 2015-12-22 | 123 | 0 |
| K153369 | SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, | Volcano Corporation | 2015-12-22 | 29 | 0 |
| K153318 | Philips Eleva Workspot with SkyFlow | Philips Medical Systems Dmc GmbH | 2015-12-22 | 34 | 0 |
| K151168 | Nexodyn AOS Wound Care Solution | Apr Applied Pharma Research SA | 2015-12-22 | 235 | 0 |
| K152852 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) | Bayer Healthcare, LLC | 2015-12-22 | 84 | 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