510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K251223 | HnX-P1, HnX-PB | H&abyz | IZL | Class II | |
| K251122 | Terragene® Bionova® BT20 Biological Indicator | Terragene LLC | FRC | Class II | |
| K251113 | iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr | Andon Health Co., Ltd | DXN | Class II | |
| K251087 | Blood Volume Analyzer (200) | Daxor Corporation | JWO | Class II | |
| K250950 | CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739) | Okapi Medical, LLC dba Resivant Medical | MPN | Class II | |
| K252094 | eZSURE™ Empty Fluid Container | Epic Medical Pte., Ltd. | KPE | Class II | |
| K251707 | IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L) | Shenzhen Huachuangtong Industrial Co., Ltd. | OHT | Class II | |
| K251652 | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo | American Medical Endoscopy | FAJ | Class II | |
| K251252 | NOBILCAM IMPAK Disc | Shandong Huge Dental Material Corporation | MQC | Unclassified | |
| K250941 | Revolution Vibe | GE Healthcare | JAK | Class II | |
| K250790 | Innovision-Dxii | DK Medical Systems Co., Ltd. | KPR | Class II | |
| K250541 | Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows | SAH | Class II | |
| K250508 | AK 98 Dialysis Machine (955607) | Baxter Healthcare Corporation | KDI | Class II | |
| K250495 | Mini Vp1 (Pl67_f); Mini Vp1 (Pl61_f) | Avizor S.A. | LRX | Class II | |
| K250381 | Deepsight NeedleVue LC1 Ultrasound System | DeepSight Technology, Inc. | IYO | Class II | |
| K250315 | Ronavis – Fx (Fx-001) | Airs Inc. | HTY | Class II | |
| K243841 | Sparta Infusion Set for Insulin | Deka Research & Development Corp. | FPA | Class II | |
| K243496 | MycoMEIA Aspergillus Assay | Pearl Diagnostics, Inc. | NOM | Class I | |
| K243483 | Access hsTnI | Siemens Healthcare Diagnostics Inc. | MMI | Class II | |
| K243462 | Diazyme Colorimetric Lithium Assay | Diazyme Laboratories, Inc. | NDW | Class II | |
| K243458 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr | Access Vascular, Inc | LJS | Class II | |
| K243448 | Equinoxe® Shoulder System | Exactech, Inc. | PHX | Class II | |
| K243427 | QuickSleeper 5 | Dentalhitec | EGM | Class II | |
| K251574 | Sleep Watch | Ambulatory Monitoring, Inc. | LEL | Class II | |
| K251561 | Biograph Trinion | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K250843 | Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K250738 | YSIO X.pree | Siemens Medical Solutions | KPR | Class II | |
| K250597 | REMEX Xcam6 | Remedi Inc. | IZL | Class II | |
| K250477 | NextAR(TM) Spine | Medacta International SA | SBF | Class II | |
| K244060 | eCO2 3D | Lutronic Corporation | ONG | Class II | |
| K243656 | U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella | United Orthopedic Corp. | MBH | Class II | |
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners | Zimmer GmbH | JDI | Class II | |
| K243455 | cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems | Roche Molecular Systems Inc | QOF | Class II | |
| K243341 | Genius AI Detection 2.0 | Hologic, Inc. | QDQ | Class II | |
| K242728 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | MSX | Class II | |
| K241461 | Mpact Constrained Liner | Medacta International SA | KWZ | Class II | |
| DEN240068 | ArteraAI Prostate | Artera | SFH | Class II | |
| K252144 | Iconix Speed Anchor; Iconix Speed HA+ Anchor | Riverpoint Medical, LLC | MBI | Class II | |
| K252032 | T65 (9016E061-) | Tonica Elektronik a/S | OBP | Class II | |
| K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs) | Acuity Surgical Devices, LLC | OVE | Class II | |
| K251706 | TENS and EMS Unit | Changsha Anxiang Medical Technology Co., Ltd | NGX | Class II | |
| K251361 | Tyber Medical Distal Radius Plating System | Tyber Medical | HRS | Class II | |
| K251319 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff | Hartalega NGC Sdn Bhd | LZA | Class I | |
| K251234 | EnSite™ X EP System | Abbott Medical | DQK | Class II | |
| K251076 | Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E) | Shenzhen Lifotronic Technology Co.,Ltd. | GEX | Class II | |
| K251060 | CORUS™ Navigation System-GX | Providence Medical Technology, Inc. | OLO | Class II | |
| K250724 | Intraosseous Infusion Needles | Spectrum Vascular | FMI | Class II | |
| K250127 | TSK Syringe | TSK Laboratory, Japan | QNQ | Class II | |
| K244007 | ArteVu | Cardio Ring Technologies, Inc. Taiwan Branch | DXN | Class II | |
| K243919 | Voxel Dosimetry (00859873006226) | Hermes Medical Solutions AB | QIH | Class II |