Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
2016 — Predicate Candidate Screening
2,956 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
137 daysmedian FDA review time
291 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161654 | NuFACE Gel Primer | Carol Cole Company | 2016-12-30 | 198 | 0 |
| K162940 | MultiBand SENSE | Philips Medical Systems Nederland B.V. | 2016-12-30 | 70 | 0 |
| K162702 | Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter | Stl International, Inc. | 2016-12-30 | 93 | 0 |
| K162604 | Cranial Reducing Tubes | Medtronic Navigation, Inc. | 2016-12-30 | 102 | 0 |
| K163180 | Hubble II | Orbbo Surgical, LLC | 2016-12-29 | 45 | 0 |
| K162180 | Disposable Insulin Syringe | Berpu Medical Technology Co., Ltd. | 2016-12-29 | 147 | 0 |
| K162531 | STERISPINE CC | Safe Orthopaedics | 2016-12-29 | 111 | 0 |
| K162375 | Envision 3D: Image Guidance System | 7D Surgical, Inc. | 2016-12-29 | 127 | 0 |
| K161613 | Hang&Go PAC | Rand S.R.L. | 2016-12-28 | 201 | 0 |
| K162692 | Kuschall K-Series Attract Manual Wheelchair | Invacare Corporation | 2016-12-28 | 92 | 0 |
| K163028 | Medline ReNewal Reprocessed Stryker External Fixation Device | Surgical Instrument Service and Savings, Inc. | 2016-12-28 | 58 | 0 |
| K162696 | Kuschall Advance Manual Wheelchair | Invacare Corporation | 2016-12-28 | 92 | 0 |
| K162675 | Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter | Masimo Corporation | 2016-12-28 | 93 | 0 |
| K161959 | ClearView cCAD | Clearview Diagnostics, Inc. | 2016-12-28 | 163 | 0 |
| K162686 | Kuschall Champion Manual Wheelchair | Invacare Corporation | 2016-12-28 | 92 | 0 |
| K160972 | Gexfix External Fixation | Gexfix International Corp. | 2016-12-28 | 266 | 0 |
| K161789 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016-12-27 | 181 | 0 |
| K163308 | SMARTO | Jeil Medical Corporation | 2016-12-27 | 34 | 0 |
| K162688 | Sysmex CS-2100i | Siemens Healthcare Diagnostics Products GmbH | 2016-12-26 | 90 | 0 |
| K163018 | Zilver 635 Biliary Stent | Cook Ireland, Ltd. | 2016-12-23 | 53 | 0 |
| K161299 | BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glu | Apex BioTechnology Corp. | 2016-12-23 | 228 | 0 |
| K162193 | XenMatrix AB Surgical Graft | C. R. Bard | 2016-12-23 | 141 | 0 |
| K163000 | AMPLATZER TorqVue 45x45 Delivery Sheath | Aga Medical COrporation (Wholly Owned by St. Jude Medical CO | 2016-12-23 | 56 | 0 |
| K163539 | Ez3D-i / E3 | Ewoosoft Co., Ltd. | 2016-12-23 | 7 | 0 |
| K162772 | ARIES GBS Assay | Luminex Corporation | 2016-12-23 | 81 | 2 |
| K162233 | Kurin Blood Culture Collection Set | Pathway, LLC | 2016-12-23 | 137 | 0 |
| K160231 | Model X-100C CO-Met™ Oximetry System | Nonin Medical, Inc. | 2016-12-23 | 326 | 0 |
| K163055 | Reprocessed Kendall SCD Express Foot Cuff | Covidien | 2016-12-23 | 52 | 0 |
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, Ca | Polymer Technology Systems, Inc. | 2016-12-22 | 562 | 0 |
| K161127 | The Small PLATEAU (PLATEAU-C) Spacer System | Life Spine, Inc. | 2016-12-22 | 245 | 0 |
| K160925 | VPS Rhythm Device with TipTracker Technology | Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) | 2016-12-22 | 262 | 1 |
| K160949 | Go Dose System | Eli Lilly and Company | 2016-12-22 | 261 | 0 |
| K160981 | Patient Monitor | Edan Instruments, Inc. | 2016-12-22 | 259 | 1 |
| K161467 | HydraGuard 10 UltraFilter | Nephros, Inc. | 2016-12-22 | 209 | 0 |
| K162282 | CardioChek Plus Test System, CardioChek Home Test System | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2016-12-22 | 129 | 0 |
| K161399 | Neocis Guidance System | Neocis, Inc. | 2016-12-22 | 216 | 0 |
| K160309 | Neurosoft TMS | Teleemg, LLC | 2016-12-22 | 322 | 0 |
| K162022 | Collagentex Rx-1 | Tanses Technologies, Inc. | 2016-12-22 | 154 | 0 |
| K162721 | Stimucel System, Stimucel Generator, Stimucel Treatment Wand | Alliqua Biomedical, Inc. | 2016-12-22 | 84 | 0 |
| K160982 | Sphynx™ | Eden Spine, LLC | 2016-12-22 | 259 | 0 |
| K162478 | ivWatch | Ivwatch, LLC | 2016-12-22 | 107 | 0 |
| K163306 | Lithoplasty Peripheral Balloon Dilatation Catheter; Lithopla | Shockwave Medical, Inc. | 2016-12-22 | 29 | 0 |
| K163068 | pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent | Q Urological Corporation | 2016-12-22 | 50 | 0 |
| K160585 | XN CAL | Streck | 2016-12-22 | 296 | 0 |
| K160588 | XN CHECK BF | Streck | 2016-12-22 | 296 | 0 |
| K161639 | Y-MIC | Micron Corporation | 2016-12-22 | 191 | 0 |
| K162446 | FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PE | Orthofix, Inc. | 2016-12-22 | 112 | 0 |
| K160590 | XN CHECK | Streck | 2016-12-22 | 296 | 0 |
| K161550 | DynaMesh-VENTRAL | Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft | 2016-12-22 | 202 | 0 |
| K162352 | derma+flex QS High Viscosity Tissue Adhesive | Chemence Medical, Inc. | 2016-12-22 | 121 | 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