Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
2020 — Predicate Candidate Screening
2,923 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
122 daysmedian FDA review time
310 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202681 | Promisemed Covered Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2020-12-31 | 107 | 0 |
| K202706 | Surgical Gown (Sterile), Surgical Gown (Non-sterile) | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2020-12-31 | 106 | 0 |
| K201239 | NuEra Tight Family, EMS Model | Bios S.R.L. | 2020-12-31 | 238 | 0 |
| K202267 | Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI | Isoray Medical, Inc. | 2020-12-31 | 142 | 0 |
| K202322 | Sim&Size | Sim&Cure | 2020-12-31 | 136 | 0 |
| K201342 | HANAROSTENT Trachea/Bronchium (CCC) | M.I.Tech Co., Ltd. | 2020-12-31 | 225 | 0 |
| K202615 | Nordiwell Medical Face Mask | Changzhou Combat Protective Equipment Co., Ltd. | 2020-12-31 | 113 | 0 |
| K203166 | PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PE | Pentax of America, Inc. | 2020-12-30 | 68 | 0 |
| K201776 | Foley Balloon Catheter for Urology | Apollon Co., Ltd. | 2020-12-30 | 184 | 0 |
| K202038 | CryoTreQ | VitreQ BV | 2020-12-30 | 160 | 1 |
| K193159 | NeuroAmp II, NeuroAmp II.5s | Corscience GmbH & Co. KG | 2020-12-30 | 411 | 0 |
| K202268 | CrossRoads Tray System | Crossroads Extremity Systems, LLC | 2020-12-30 | 141 | 0 |
| K202372 | Upper Arm Electronic Blood Pressure Monitor | Conmo Electronic Company Limited | 2020-12-30 | 133 | 0 |
| K203239 | Arthrex Low Profile Screws | Arthrex, Inc. | 2020-12-30 | 57 | 0 |
| K201754 | JianYu Surgical Mask | Jiangsu Jianyu Health Medical Co., Ltd. | 2020-12-30 | 184 | 0 |
| K202690 | Remunity Pump for Remodulin (treprostinil) Injection | Deka Research and Development | 2020-12-30 | 106 | 0 |
| K202455 | Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Super | Supersonic Imagine | 2020-12-29 | 124 | 0 |
| K203511 | Baby Gorilla/Gorilla Plating System | Paragon 28, Inc. | 2020-12-29 | 29 | 0 |
| K202940 | First Relief v1 | Dyansys, Inc. | 2020-12-29 | 90 | 0 |
| K200965 | XR-MX/1000 | Karl Storz Endoscopy America, Inc. | 2020-12-29 | 263 | 0 |
| K203508 | BriefCase | Aidoc Medical , Ltd. | 2020-12-29 | 29 | 0 |
| K202699 | E-Cath STIM acc. Tsui | PAJUNK GmbH Medizintechnologie | 2020-12-29 | 104 | 0 |
| K203137 | Venue Fit | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-12-29 | 70 | 1 |
| K202456 | M5 Recorder | Global Instrumentation, LLC | 2020-12-29 | 124 | 0 |
| K203219 | Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever | Stryker Neurovascular | 2020-12-29 | 57 | 0 |
| K200970 | Self-Contained Biological Indicator | True Indicating, LLC | 2020-12-28 | 259 | 0 |
| K202248 | Attune Revision Sleeve LPS Femoral Adaptors | Depuy Ireland UC | 2020-12-28 | 140 | 0 |
| K201781 | Uni-FuZe-P Bone Putty | Zavation Medical Products, LLC | 2020-12-28 | 181 | 0 |
| K202454 | Smart SPACE Shoulder System | Techmah Medical, LLC | 2020-12-28 | 123 | 0 |
| K200968 | ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC3 | Insung Medical Co., Ltd. | 2020-12-28 | 262 | 0 |
| K202730 | Quadra-P | Medacta International S.A. | 2020-12-28 | 101 | 0 |
| K201800 | Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port- | Nanoray Co., Ltd. | 2020-12-28 | 181 | 0 |
| K203062 | Optiflux Series of Dialyzers F160NR, F180NR, F200NR | Fresenius Medical Care Renal Therapies Group, LLC | 2020-12-28 | 80 | 0 |
| K200321 | Novaerus NV1050 | Novaerus Us, Inc. | 2020-12-28 | 322 | 0 |
| K200458 | Tailored-C Cervical Interbody Fusion System | Bespoke Technologies | 2020-12-28 | 307 | 0 |
| K193419 | MBT Sepsityper | Bruker Daltonik GmbH | 2020-12-27 | 384 | 0 |
| K201747 | 8-CH Electroencephalography Amplifier | Hipposcreen Neurotech Corp. | 2020-12-27 | 184 | 0 |
| K202485 | ImPACT Version 4 | Impact Applications, Inc. | 2020-12-25 | 116 | 0 |
| K200422 | Image Quality Analyzer (IQA) | Visionquest Biomedical, Inc. | 2020-12-24 | 308 | 0 |
| K200426 | Acute Dual Lumen Hemodialysis Catheter | Health Line International Corporation | 2020-12-24 | 307 | 0 |
| K203544 | UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery | Lumenis, Ltd. | 2020-12-24 | 20 | 0 |
| K192073 | Helix Genetic Health Risk App for late-onset Alzheimer’s dis | Helix Opco, LLC | 2020-12-23 | 509 | 0 |
| K203467 | WishBone Medical Plate and Screw System | Wishbone Medical, Inc. | 2020-12-23 | 28 | 0 |
| K202061 | Medical Face mask | Jiangsu Province Jianerkang Medical Dressing Co., Ltd. | 2020-12-23 | 149 | 0 |
| K193670 | SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Bloo | Quanta Dialysis Technologies, Ltd. | 2020-12-23 | 358 | 0 |
| K202431 | ControlRad Select Model Z | Controlrad, Inc. | 2020-12-23 | 120 | 0 |
| K202526 | OmniTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2020-12-23 | 113 | 1 |
| K202353 | SR-2300 Portable DR Imaging System, SR-2300S Portable DR Ima | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2020-12-23 | 127 | 0 |
| K202637 | F3D Corpectomy System | Corelink, LLC | 2020-12-23 | 103 | 0 |
| K200631 | DeRoyal Temperature Monitoring Probe | Deroyal Industries, Inc. | 2020-12-23 | 288 | 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