FDA clearances & recalls - week 25, 2026
FDA cleared 68 devices through the 510(k) pathway in week 25 of 2026 (2026-06-22 to 2026-06-27), down 24% from the prior week's 89. Neurology led with 10 clearances. Average review time for the week's cohort was 176 days; the fastest decision was Health Line Tearaway Introducer (K261950) at 12 days. FDA also posted 50 device recalls.
68510(k) clearances
50recalls posted
176 daysaverage review, this cohort
-24%vs prior week
By specialty
Clearances (top 50 of 68)
| Device | Applicant | Specialty | Decided | Review days |
|---|---|---|---|---|
| BraiN20® (BraiN20) | Time IS Brain, S.L. | Neurology | 2026-06-27 | 271 |
| MIST IC | Imagine Milling Technologies, LLC | Dental | 2026-06-27 | 85 |
| SOMNUM (SOMNUM) | Honeynaps Co., Ltd. | Neurology | 2026-06-27 | 270 |
| VERTICALE® Navigation Instruments | Silony Medical GmbH | Neurology | 2026-06-26 | 200 |
| Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reu | Cadwell Industries, Inc. | Neurology | 2026-06-26 | 57 |
| PhAST instrument and PhAST Blood Culture Gram-negative Panel | Phast Corp. | Microbiology | 2026-06-26 | 269 |
| BioHorizons CEREC Compatible Ti-Bases | BioHorizons Implant Systems, Inc. | Dental | 2026-06-26 | 169 |
| Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5 | Ziree Co., Ltd. | Physical Medicine | 2026-06-26 | 71 |
| BioTracker 2.0 | Biotracker, LLC | 2026-06-26 | 270 | |
| Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) | Shenzhen Changkun Technology Co., Ltd. | Obstetrics/Gynecology | 2026-06-26 | 532 |
| SALGINA 2.5mm Distal Radius System | Bonebridge AG | Orthopedic | 2026-06-26 | 63 |
| Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | Cardiovascular | 2026-06-26 | 56 |
| MammoScreen® (5) | Therapixel | Radiology | 2026-06-26 | 113 |
| LightningWire Transseptal Puncture System (TPS) | ElectroWire Medical | Cardiovascular | 2026-06-26 | 30 |
| ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); EC | Edwards Lifesciences | General, Plastic Surgery | 2026-06-26 | 179 |
| i-STAT Crea cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Clinical Chemistry | 2026-06-26 | 88 |
| TENS 7000 Rechargeable 4 Channel (TENS 7000H) | Shenzhen Dongdixin Technology Co., Ltd. | Neurology | 2026-06-26 | 137 |
| Arthrex FiberButton | Arthrex, Inc. | Orthopedic | 2026-06-26 | 172 |
| ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Sl | Longeviti Neuro Solutions | Neurology | 2026-06-25 | 113 |
| mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCAR | Seers Technology Co., Ltd. | Cardiovascular | 2026-06-25 | 268 |
| SimplGuide | Pendracare | Cardiovascular | 2026-06-25 | 71 |
| UNIQA® Dental Implants System | Uniqa Dental, Ltd. | Dental | 2026-06-25 | 434 |
| Jabra Enhance Select Self-fit (Jabra Enhance Select 550) | GN Hearing A/S | Ear, Nose, Throat | 2026-06-25 | 188 |
| iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Pr | Neuralytix | Ear, Nose, Throat | 2026-06-25 | 91 |
| Wearable breast pump (QY-101, QY-102, QY-108) | Shenzhen Qinyi Electronic Technology Co., Ltd. | Obstetrics/Gynecology | 2026-06-25 | 87 |
| Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C | Weyo Surgical Technology , Ltd. | Obstetrics/Gynecology | 2026-06-25 | 314 |
| ATTUNE Total Knee System; ATTUNE Cementless Knee System | DePuy Ireland UC | Orthopedic | 2026-06-25 | 55 |
| VELYS™ Robotic-Assisted Solution | Depuy Ireland UC | Neurology | 2026-06-25 | 132 |
| G-Series Grind Guard | ASESSO HEALTH, Inc. | Unknown | 2026-06-25 | 106 |
| EliA CTD 13 Screen | Phadia AB | Immunology | 2026-06-25 | 268 |
| Arthrex Sterile VAL and VAL KreuLock™ Compression Screw Syst | Arthrex, Inc. | Orthopedic | 2026-06-25 | 105 |
| A5 Anesthesia System (A5); A7 Anesthesia System (A7) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Anesthesiology | 2026-06-25 | 268 |
| Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture | ETHICON, Inc. | General, Plastic Surgery | 2026-06-25 | 268 |
| IntraOp Alignment System; CONTOUR3D Bending System | Alphatec Spine, Inc. | Orthopedic | 2026-06-25 | 269 |
| syngo.CT Coronary Cockpit | Siemens Medical Solutions USA, Inc. | Radiology | 2026-06-25 | 211 |
| DVT Garment | Vistar Medical Supplies Co., Ltd. | Cardiovascular | 2026-06-25 | 268 |
| BedDot (G1) | Intelligent Dots, LLC | Anesthesiology | 2026-06-25 | 269 |
| MiPACS V5 (1.0.0) | Apryse Software Corp | Radiology | 2026-06-25 | 150 |
| Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK | Shanghai Waylong Intelligent Technology Co.,Ltd | Physical Medicine | 2026-06-24 | 96 |
| Enhanced Boundary for PCCT | Ge Medical Systems, LLC | Radiology | 2026-06-24 | 219 |
| Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. | Unknown | 2026-06-24 | 86 |
| Target Xtra Detachable Coil | Stryker Neurovscular | Neurology | 2026-06-24 | 26 |
| Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-52 | Hangzhou AGS MedTech Co., Ltd. | Gastroenterology, Urology | 2026-06-24 | 267 |
| CLEAR™ Aspiration System | Insera Therapeutics, Inc. | 2026-06-24 | 267 | |
| AMSCO 700 Steam Sterilizer | STERIS Corporation | General Hospital | 2026-06-24 | 85 |
| Biodegradable Powder Free Nitrile Examination Glove, Blue Co | Sw Technologies, Inc. | General Hospital | 2026-06-24 | 352 |
| ConvaVAC™ Negative Pressure Wound Therapy System | Convatec Limited, Gdc Building | General, Plastic Surgery | 2026-06-24 | 268 |
| Ceribell Neurology Review Software | Ceribell, Inc. | Neurology | 2026-06-24 | 90 |
| HD Camera Head OLYMPUS CH-S200-08-LB | Olympus Medical Systems Corporation | Gastroenterology, Urology | 2026-06-24 | 69 |
| Hydrophilic coated intermittent nalaton catheter for single | Hangzhou Jimushi Meditech Co., Ltd. | Gastroenterology, Urology | 2026-06-24 | 138 |
Recalls posted
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