FDA clearances & recalls - week 17, 2026
FDA cleared 71 devices through the 510(k) pathway in week 17 of 2026 (2026-04-27 to 2026-05-01), up 0% from the prior week's 71. Orthopedic led with 13 clearances. Average review time for the week's cohort was 168 days; the fastest decision was UltraEZ (K261404) at 1 days. FDA also posted 50 device recalls.
71510(k) clearances
50recalls posted
168 daysaverage review, this cohort
+0%vs prior week
By specialty
Clearances (top 50 of 71)
| Device | Applicant | Specialty | Decided | Review days |
|---|---|---|---|---|
| Phototherapy System (DUV-COMBO) | Choyang Medics Co., Ltd. | General, Plastic Surgery | 2026-05-01 | 123 |
| Zeta Navigation System | Zeta Surgical, Inc. | Neurology | 2026-05-01 | 162 |
| BioCode® Respiratory Pathogen Panel (RPP) | Applied BioCode, Inc. | Microbiology | 2026-05-01 | 130 |
| ABL90 FLEX PLUS System | Radiometer Medicals Aps | Clinical Chemistry | 2026-05-01 | 266 |
| ABL90 FLEX PLUS System | Radiometer Medicals Aps | Clinical Chemistry | 2026-05-01 | 267 |
| ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | Orthopedic | 2026-05-01 | 254 |
| FX V135 EASYTECH® Shoulder System | FX Shoulder Solutions, Inc. | Orthopedic | 2026-05-01 | 130 |
| Capnostream™35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC | Anesthesiology | 2026-05-01 | 224 |
| Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Senso | Philips Medizin Systeme | Cardiovascular | 2026-05-01 | 148 |
| VOCO Profluorid Varnish + BioMin | Voco GmbH | Dental | 2026-05-01 | 303 |
| BIOMONITOR IV (471155) | Biotronik, Inc. | Cardiovascular | 2026-05-01 | 30 |
| OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO , Ltd. | Orthopedic | 2026-05-01 | 134 |
| Verifine Safety Lancets | Promisemed Hangzhou Meditech Co., Ltd. | General, Plastic Surgery | 2026-05-01 | 31 |
| Prolystica Pass Thru Disinfectant Wipes | Steris | General Hospital | 2026-05-01 | 505 |
| Oxiplex | Fziomed, Inc. | Orthopedic | 2026-05-01 | 213 |
| Tutamen Self Adhesive Electrodes | Dongguan Tutamen Metalwork Co., Ltd. | Neurology | 2026-05-01 | 270 |
| Any-Com Seal | Mediclus Co., Ltd. | Dental | 2026-05-01 | 49 |
| PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA | Orthopedic | 2026-05-01 | 141 |
| EndoTool IV Cloud 1.0 | Glooko, Inc. | Anesthesiology | 2026-05-01 | 43 |
| Ancora-SB | Aspero Medical, Inc. | Gastroenterology, Urology | 2026-05-01 | 91 |
| Ambu® Virobac II® Exhalation Filter | Ambu A/S | Anesthesiology | 2026-04-30 | 342 |
| AllTest Strep A Rapid Test | Hangzhou AllTest Biotech Co., Ltd. | Microbiology | 2026-04-30 | 87 |
| Bayesian Health Sepsis Flagging Device | Bayesian Health, Inc. | General Hospital | 2026-04-30 | 420 |
| BEE PLIF Cage | NGMedical GmbH | Orthopedic | 2026-04-30 | 29 |
| AffloVest® Mobile Airway Clearance Therapy | Tactile Medical | Anesthesiology | 2026-04-30 | 234 |
| OrthoPediatrics® Locking Cannulated Blade Plate System | OrthoPediatrics Corp. | Orthopedic | 2026-04-30 | 90 |
| BloodSTOP iX Trauma Matrix (TM-iX-20) | Lifescience Plus, Inc. | Unknown | 2026-04-30 | 223 |
| Synapse 3D Base Tools (V7.2) | Fujifilm Corporation | Radiology | 2026-04-30 | 128 |
| iLet ACE Pump | Beta Bionics, Inc. | Clinical Chemistry | 2026-04-30 | 139 |
| FSYX Ocular Pressure Adjusting Pump | Balance Ophthalmics, Inc. | Ophthalmic | 2026-04-30 | 268 |
| Aurie System | Cathbuddy, Inc. | Gastroenterology, Urology | 2026-04-30 | 328 |
| Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy | Xiamen Weiyou Intelligent Technology Co., Ltd. | Physical Medicine | 2026-04-30 | 220 |
| 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KM | Kms Medical Technology Co., Ltd. | Gastroenterology, Urology | 2026-04-30 | 233 |
| Intelligent NR | Canon, Inc. | Radiology | 2026-04-30 | 265 |
| c-med0 alpha | Cosinuss GmbH | Cardiovascular | 2026-04-30 | 211 |
| UltraEZ | Ultradent Products, Inc. | Dental | 2026-04-30 | 1 |
| syngo Application Software | Siemens Medical Solutions USA, Inc. | Radiology | 2026-04-29 | 127 |
| SCRIPT™ Implant System | Globus Medical, Inc. | Orthopedic | 2026-04-29 | 211 |
| ES-Series | E-Scopics | Radiology | 2026-04-29 | 68 |
| Paptizer 360 | LiViliti Health Products Corporation | General Hospital | 2026-04-29 | 266 |
| Break Wave | Sonomotion, Inc. | Gastroenterology, Urology | 2026-04-29 | 28 |
| YellowStar | Asclepion Laser Technologies GmbH | General, Plastic Surgery | 2026-04-29 | 27 |
| PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHIL | GEO MEDICAL CO., LTD. | Ophthalmic | 2026-04-29 | 146 |
| F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | BMC Medical Co., Ltd. | Anesthesiology | 2026-04-29 | 215 |
| LEO Spinal System | ZheJiang Decans Medical Devices Co., Ltd. | Orthopedic | 2026-04-29 | 260 |
| Echo Large Bore Introducer Sheath | Echo Medical, LLC | Cardiovascular | 2026-04-29 | 64 |
| Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 | Scientia Vascular, Inc. | Cardiovascular | 2026-04-29 | 163 |
| Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B | Shenzhen Root Innovation Technology Co., Ltd. | Obstetrics/Gynecology | 2026-04-29 | 142 |
| DeepHealth ProstateAI | Quantib B.V. | Radiology | 2026-04-29 | 159 |
| Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, | Dolanvy (Suzhou) Medical Technology Co., Ltd. | Gastroenterology, Urology | 2026-04-28 | 235 |
Recalls posted
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