FDA clearances & recalls - week 19, 2026
FDA cleared 77 devices through the 510(k) pathway in week 19 of 2026 (2026-05-11 to 2026-05-16), up 60% from the prior week's 48. Radiology led with 17 clearances. Average review time for the week's cohort was 150 days; the fastest decision was Y-Knotless™ Flex Anchors (K261363) at 16 days. FDA also posted 50 device recalls.
77510(k) clearances
50recalls posted
150 daysaverage review, this cohort
+60%vs prior week
By specialty
Clearances (top 50 of 77)
| Device | Applicant | Specialty | Decided | Review days |
|---|---|---|---|---|
| BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | Orthopedic | 2026-05-16 | 61 |
| Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Ceme | Depuy Ireland UC | Orthopedic | 2026-05-15 | 87 |
| NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut | Hycor Biomedical | Immunology | 2026-05-15 | 127 |
| Manual Tissue Removal Device | Suzhou AcuVu Medical Technology Co., Ltd. | Obstetrics/Gynecology | 2026-05-15 | 149 |
| NovaLine Tubing Set for Hemodialysis (BL 124) | Bain Medical Equipment (Guangzhou) Co., Ltd. | Gastroenterology, Urology | 2026-05-15 | 287 |
| Stellaris Elite™ vision enhancement system; Posterior and Co | Bausch and Lomb | Ophthalmic | 2026-05-15 | 29 |
| Varion Thoracolumbar Fixation System | Kyocera Medical Technologies Inc. (KMTI) | Orthopedic | 2026-05-15 | 51 |
| medXion NEXUS | medXion Technologies, Inc. | Radiology | 2026-05-15 | 157 |
| NxStage System One with NxView | Fresenius Medical Care Renal Therapies Group, LLC | Gastroenterology, Urology | 2026-05-15 | 289 |
| SubtleHD-CT (1.x) | Subtle Medical, Inc. | Radiology | 2026-05-15 | 147 |
| KARL STORZ Laryngoscopes and Accessories | KARL STORZ Endoscopy-America, Inc. | Ear, Nose, Throat | 2026-05-15 | 270 |
| Ventana® P/T Lumbar Interbody System | Spinal Elements, Inc. | Orthopedic | 2026-05-15 | 87 |
| Embryo Predict | Alife Health | Obstetrics/Gynecology | 2026-05-15 | 427 |
| Neurophet SCALE PET | Neurophet., Inc. | Radiology | 2026-05-15 | 274 |
| uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Eli | Wuhan United Imaging Healthcare Co.,Ltd | Radiology | 2026-05-15 | 172 |
| cobas liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. | Microbiology | 2026-05-15 | 171 |
| Introcan Safety® Deep Access XL IV Catheter | B.Braun Medical, Inc. | General Hospital | 2026-05-15 | 228 |
| Digital Color Doppler Ultrasound System (Autra RS, Autra 90, | Sonoscape Medical Corp. | Radiology | 2026-05-15 | 150 |
| Jada System (Jada-2002) | Organon, LLC | Obstetrics/Gynecology | 2026-05-15 | 177 |
| cobas liat CT/NG nucleic acid test | Roche Molecular Systems, Inc. | Microbiology | 2026-05-15 | 171 |
| UNiD™ Spine Analyzer (SW3002) | Medicrea International S.A.S. (Medtronic) | Radiology | 2026-05-15 | 25 |
| TruSelect™ 2.6 Microcatheter | Boston Scientific Corporation | Cardiovascular | 2026-05-15 | 67 |
| Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN00 | Shenzhen Root Innovation Technology Co., Ltd. | General, Plastic Surgery | 2026-05-15 | 119 |
| Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled | Teleflex Medical Sdn. Bhd. | Anesthesiology | 2026-05-15 | 267 |
| Neurophet AQUA | Neurophet., Inc. | Radiology | 2026-05-15 | 28 |
| MatriDerm | Medskin Solutions Dr. Suwelack AG | Unknown | 2026-05-14 | 30 |
| ARIES Anterior Cervical Plate Systems | ZheJiang Decans Medical Devices Co., Ltd. | Orthopedic | 2026-05-14 | 254 |
| Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A- | Hunan Accurate Bio-Medical Technology Co., Ltd. | Gastroenterology, Urology | 2026-05-14 | 269 |
| ART.1-US | Seetreat Pty, Ltd. | Radiology | 2026-05-14 | 233 |
| ET Healing Abutments; ET Scan Healing Abutments; EK Scan Hea | Hiossen, Inc. | Dental | 2026-05-14 | 226 |
| BriefCase-Triage | Aidoc Medical , Ltd. | Radiology | 2026-05-14 | 23 |
| Dormiva Anti-Snoring Mouth Guard | Koncept Innovators, Inc. | Dental | 2026-05-14 | 37 |
| Palmtop Ultrasound Diagnostic System (MT10P/MT10) | Mytech Intelligence (Shenzhen) Co., Ltd. | Radiology | 2026-05-14 | 120 |
| Suction Pump (SU-90) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | General, Plastic Surgery | 2026-05-14 | 57 |
| ENTity USB Videoscope System | Optim, LLC | Ear, Nose, Throat | 2026-05-14 | 143 |
| Bonalive Maxillofacial | Bonalive , Ltd. | Dental | 2026-05-14 | 161 |
| SmartClip Delivery Catheter (ADR-1715) | Elucent Medical | Ear, Nose, Throat | 2026-05-14 | 84 |
| SubtleHD-PET (1.x) | Subtle Medical, Inc. | Radiology | 2026-05-14 | 150 |
| Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U | Shenzhen Urion Technology Co., Ltd. | Cardiovascular | 2026-05-14 | 148 |
| TriMed Compression Screws | TriMed, Inc. | Orthopedic | 2026-05-14 | 29 |
| Any-Etch | Mediclus Co., Ltd. | Dental | 2026-05-14 | 90 |
| RAYMO Mobile X-ray System (Model: RAYMO) | DRGEM Corporation | Radiology | 2026-05-14 | 122 |
| CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PC | Providence Medical Technology, Inc. | Unknown | 2026-05-14 | 174 |
| Disposable Syringes with Accessories for Power Injectors (90 | Fortis Biosolutions Company Limited | Cardiovascular | 2026-05-14 | 265 |
| Electric Wheelchair (Y207BL) | Jiangsu Intco Medical Products Co., Ltd. | Physical Medicine | 2026-05-13 | 226 |
| SURGIMAGE SIM 1000H Fluorescence Imaging Platform | Surgimage Corporation | Radiology | 2026-05-13 | 229 |
| ACIST Pro Diagnostic System (019304); Processing Unit Bed Mo | Acist Medical Systems, Inc. | Cardiovascular | 2026-05-13 | 264 |
| Portable Neuromodulation Stimulator (PoNS) | Helius Medical, Inc. | Neurology | 2026-05-13 | 233 |
| Morph | BeauBrain Healthcare, Inc. | Radiology | 2026-05-13 | 127 |
| Y-Knotless™ Flex Anchors | CONMED Corporation | Orthopedic | 2026-05-13 | 16 |
Recalls posted
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