Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
2022 — Predicate Candidate Screening
3,209 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
146 daysmedian FDA review time
407 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223605 | ControlSeal Electrode (ELSB) | Coapt | 2022-12-30 | 28 | 1 |
| K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1 | AtriCure, Inc. | 2022-12-30 | 233 | 0 |
| K222767 | PeekMed web (v1) | Peek Health, S.A. | 2022-12-30 | 108 | 0 |
| K222010 | Biobeat Platform-2 and BB-613WP Patch | Biobeat Technologies , Ltd. | 2022-12-30 | 176 | 0 |
| K210313 | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for | Shanghai Microport EP Medtech Co., Ltd. | 2022-12-30 | 695 | 0 |
| K221796 | Cyware 4H and Cysart 4H | Abys Medical | 2022-12-30 | 192 | 0 |
| K222195 | aprevo® Digital Workflow | Carlsmed, Inc. | 2022-12-30 | 161 | 0 |
| K223616 | Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) De | Boston Scientific Corporation | 2022-12-30 | 25 | 0 |
| K222002 | Persyst 15 EEG Review and Analysis Software | Persyst Development Corporation | 2022-12-30 | 176 | 0 |
| K223687 | X-ray Flat Panel Detectors (EverestView 4343X) | Careray Digital Medical Technology Co., Ltd. | 2022-12-30 | 21 | 0 |
| K214041 | Aesculap AICON Container | Aesculap, Inc. | 2022-12-30 | 372 | 0 |
| K222872 | DNA Appliance | Vivos Therapeutics, Inc. | 2022-12-30 | 99 | 0 |
| K213260 | CMFlexTM | Dimension Inx Corp. | 2022-12-30 | 456 | 0 |
| K213430 | Fingertip Pulse Oximeter | Shenzhen Witleaf Medical Electronics Co., Ltd. | 2022-12-30 | 435 | 0 |
| K222984 | BioClean Implant Restorative System | Bioclean Dental, LLC | 2022-12-29 | 92 | 0 |
| K223603 | Reflow System Mini and ReFlow Mini Flusher | Anuncia Medical, Inc. | 2022-12-29 | 27 | 0 |
| K221477 | AG100s | Hospitech Respiration , Ltd. | 2022-12-29 | 220 | 0 |
| K223592 | Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) | Boston Scientific Corporation | 2022-12-29 | 28 | 0 |
| K221690 | OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO | Olympus Medical Systems Corp. | 2022-12-29 | 202 | 3 |
| K211619 | Multi-Parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | 2022-12-29 | 582 | 0 |
| K221859 | Atalante | Wandercraft SAS | 2022-12-29 | 185 | 1 |
| K211557 | EndoPATx | Itamar Medical , Ltd. | 2022-12-29 | 589 | 0 |
| K221981 | SafeR Syringe and SafeR Sting | Roncadelle Operations Srl | 2022-12-29 | 177 | 0 |
| K221333 | Acumed Acutrak System- MR Conditional, Acumed Acturak 2 Syst | Acumed, LLC | 2022-12-29 | 234 | 4 |
| K223324 | Total Bilirubin2 | Abbott Ireland Diagnostics Division | 2022-12-29 | 59 | 0 |
| K220935 | Digital Dialysis Clinic - Intelligent Dialysis Assistant (ID | Iren-Medical, Ltd. | 2022-12-29 | 273 | 0 |
| K222528 | Well-Life Probe Electrode for Stimulation/EMG Probe (Model: | Well-Life Healthcare Limited | 2022-12-29 | 129 | 0 |
| K223647 | CLEAR+BRILLIANT TOUCH® Laser System | Solta Medical, Inc. | 2022-12-29 | 23 | 0 |
| K223286 | BD AutoShield Duo™ Pen Needle | Becton, Dickinson and Company | 2022-12-28 | 64 | 0 |
| K222760 | StageOne™ Select Hip Cement Spacer Molds | Biomet, Inc. | 2022-12-28 | 106 | 0 |
| K223654 | Medussa-PL Cage | Medyssey USA, Inc. | 2022-12-28 | 22 | 0 |
| K221660 | RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP | Olympus Medical Systems Corp. | 2022-12-28 | 203 | 1 |
| K221344 | nView s1 with nav option | Nview Medical | 2022-12-28 | 233 | 0 |
| K220974 | R:GEN | Lutronic Vision, Inc. | 2022-12-27 | 267 | 0 |
| K223094 | EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Ena | ABBOTT MEDICAL | 2022-12-27 | 88 | 0 |
| K221990 | Access Total ßhCG (5th IS) | Beckman Coulter, Inc. | 2022-12-27 | 174 | 0 |
| K222978 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022-12-27 | 90 | 0 |
| K221669 | IOB Warming Blankets | Iob Medical, Inc. | 2022-12-27 | 201 | 0 |
| K214002 | CRYOcheck Chromogenic Factor IX | Precision Biologic, Inc. | 2022-12-23 | 367 | 0 |
| K223565 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System | L&K BIOMED Co., Ltd. | 2022-12-23 | 24 | 0 |
| DEN220017 | BioXmark | Nanovi A/S | 2022-12-23 | 294 | 0 |
| K211485 | STA- NeoPTimal | Diagnostica Stago S.A.S | 2022-12-23 | 589 | 0 |
| K210017 | ACTOnco, ACTOnco IVD | Act Genomics | 2022-12-23 | 718 | 0 |
| K212239 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | 2022-12-23 | 522 | 0 |
| K223289 | Access Vitamin B12 | Beckman Coulter, Inc. | 2022-12-23 | 59 | 0 |
| K222164 | Visant Medical Canalicular Plug | Visant Medical, Inc. | 2022-12-23 | 155 | 0 |
| K221048 | Episealer Patellofemoral System | Episurf Medical, Inc. | 2022-12-23 | 259 | 0 |
| K222726 | Smartpump 3.0 Double Electric Breast Pump | Lansinoh Laboratories | 2022-12-23 | 106 | 0 |
| K222924 | Leg Massager RF-ALM070 | Shenzhen Ruiyi Business Technology Co., Ltd. | 2022-12-23 | 88 | 0 |
| K223442 | MR 5300 and MR 7700 R11 MR Systems | Philips Medical Systems Nederlands B.V. | 2022-12-23 | 39 | 3 |
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