Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
2021 — Predicate Candidate Screening
3,023 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
135 daysmedian FDA review time
361 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211263 | Intrelief | Easymed Instruments Co., Ltd. | 2021-12-30 | 248 | 0 |
| K212834 | Disposable Nitrile Medical Examination Glove (Tested for Use | Siyang Threeguard Medical Supplies Co., Ltd. | 2021-12-30 | 114 | 0 |
| K211159 | eco-x Series (eco-x, eco-x-s) | Hdx Will Corp. | 2021-12-30 | 255 | 0 |
| K202898 | Tzoar 207 Negative Pressure Wound Therapy (NPWT) System | Lightstone Medical Products (Ningbo) Co, Ltd. | 2021-12-30 | 457 | 0 |
| K212547 | Quick-Start Screws | Innovate Orthopaedics Limited | 2021-12-30 | 139 | 0 |
| K213538 | Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid G | Acuity Polymers, Inc. | 2021-12-30 | 52 | 0 |
| K211458 | Disposable Anorectal Staplers, Disposable Intraluminal Stapl | Ningbo Verykind Medical Device Co., Ltd. | 2021-12-30 | 233 | 0 |
| K213776 | LiverSmart | Resonance Health Analysis Services Pty, Ltd. | 2021-12-29 | 27 | 0 |
| K213073 | Goody Gloves, Wincare, TBG Gloves | Thai Rubber Gloves Co., Ltd. | 2021-12-29 | 97 | 0 |
| K211156 | CONVIVO In Vivo Pathology Suite | Carl Zeiss Meditec, AG | 2021-12-29 | 254 | 0 |
| K212656 | Flexible Intubation Video Endoscope – Sterile (FIVE-S) | Karl Storz Endoscopy America | 2021-12-29 | 128 | 1 |
| K213316 | Life Scope PT BSM-1700 Series, AY Series, Data Acquisition U | Nihon Kohden Corporation | 2021-12-29 | 86 | 0 |
| K202101 | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotti | Accriva Diagnostics, Inc. | 2021-12-29 | 518 | 1 |
| K212806 | Alcon (serafilcon A) soft contact lenses for daily wear | Alcon Laboratories, Inc. | 2021-12-28 | 116 | 0 |
| K213209 | EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip | K1 Medical, LLC | 2021-12-28 | 90 | 0 |
| K213016 | ATM Glove | Phu Duc Huy Production Trading Services Corporation | 2021-12-28 | 99 | 0 |
| K213763 | Sonosite PX Ultrasound System | FUJIFILM Sonosite, Inc. | 2021-12-27 | 26 | 0 |
| K212716 | Dermoaroma Disposable Nitrile Examination Glove | Chuzhou Harmony Gloves Medical Technology Co.,Ltd | 2021-12-27 | 122 | 0 |
| K212848 | Sterile Latex Surgical Gloves Powder Free | Pentavest Holdings Sdn Bhd | 2021-12-27 | 111 | 0 |
| K193138 | Colibri System | Copan Wasp Srl | 2021-12-27 | 775 | 0 |
| K203523 | Fixone hybrid knotless anchor | Aju Pharm Co., Ltd. | 2021-12-25 | 389 | 8 |
| K211770 | R3ACT Stabilization System | Paragon 28, Inc. | 2021-12-25 | 200 | 0 |
| K202255 | Skypro, SP02 Mask (3) | Skypro Medical Supplies Company | 2021-12-24 | 501 | 0 |
| K213136 | CPL Surgical Face Mask | Control Print Limited | 2021-12-24 | 88 | 0 |
| K212921 | Nitrile Examination Golves Powder Free | Jiangsu Standard Health Co.,Ltd | 2021-12-24 | 101 | 0 |
| K213208 | Twist Drills | Biomet Microfixation | 2021-12-23 | 85 | 0 |
| K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent T | Nu Vasive, Incorporated | 2021-12-23 | 367 | 0 |
| K193407 | Contour® next GEN Blood Glucose Monitoring System | Ascensia Diabetes Care | 2021-12-23 | 745 | 1 |
| K210992 | Altech® Exhalation Valve (Single Limb and Dual Limb) | Meditera Tibbi Malzeme San VE Tic AS | 2021-12-23 | 265 | 0 |
| K212436 | NBR Synthetic Nitrile Examination Gloves | Shandong Langtai International Trade Co., Ltd. | 2021-12-23 | 141 | 0 |
| K212088 | Integrity Implants Navigated Instruments | Integrity Implants, Inc. | 2021-12-23 | 170 | 0 |
| K210976 | Curian Campy | Meridian Bioscience, Inc. | 2021-12-23 | 266 | 0 |
| K213479 | D²RS and D²RS 9090 | Stephanix | 2021-12-23 | 55 | 0 |
| K213766 | dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWris | Invivo Corporation | 2021-12-23 | 22 | 0 |
| K213219 | Vy Spine™ VyWasher™ Buttress System | Vy Spine, LLC | 2021-12-23 | 85 | 0 |
| K213547 | SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth | Ttk Healthcare Limited | 2021-12-23 | 45 | 0 |
| K202788 | Sonomed IV, Sonomed V | Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto | 2021-12-23 | 457 | 0 |
| K210147 | Unico High Performance Surgical Mask, Unico High Performance | Unicoglobal, Inc. | 2021-12-22 | 335 | 0 |
| K213691 | Solas OR | Cirdan Imaging, Ltd. | 2021-12-22 | 29 | 0 |
| K213094 | ID-500 iRestore Hair Growth System | Freedom Laser Therapy, Inc. | 2021-12-22 | 89 | 0 |
| K212914 | Glovmaster Nitrile Examination Glove Powder Free | Glovmaster Sdn. Bhd. | 2021-12-22 | 100 | 0 |
| K213428 | EdgePro | Biolase, Inc. | 2021-12-22 | 62 | 0 |
| K210978 | BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spin | Becton, Dickinson and Company | 2021-12-22 | 265 | 0 |
| K213144 | Biodegradable Powder Free Vinyl Examination Gloves Blue, Gre | Shen Wei USA, Inc. | 2021-12-22 | 86 | 0 |
| K212285 | Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, C | Oriental Inspiration Limited | 2021-12-22 | 154 | 0 |
| K211691 | Ultrast Gel | Ultrast, Inc. | 2021-12-22 | 203 | 0 |
| K213159 | Encore System | Siesta Medical, Inc. | 2021-12-22 | 85 | 0 |
| K213207 | Sheath, Stopcock Accessory | Olympus Winter & Ibe GmbH | 2021-12-22 | 84 | 0 |
| K210305 | Pulse Oximeter | Dongguan Lingxin Technologies Co., Ltd. | 2021-12-22 | 322 | 0 |
| K202404 | BoneMRI | Mriguidance B.V. | 2021-12-22 | 488 | 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