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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K091609 | Newdeal Compression Plate | Newdeal SAS | HRS | Class II | |
| K091391 | Uroplasty Rigid Endoscopic Needle, Mrn-518 | Uroplasty, LLC | FBK | Class II | |
| K090984 | Inertia Pedicle Screw System | Nexxt Spine LLC | MNI | Class II | |
| K090923 | Parcus Graft Fixation System | Parcus Medical, L.L.C. | MBI | Class II | |
| K090910 | Hanso Acupuncture Needle | Hansol Medical Co. | MQX | Class II | |
| K090807 | Regional Oximeter System, Model 7600 | Nonin Medical, Inc | MUD | Class II | |
| K090596 | Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and Greater Trochanter Antegrade Fem | Zimmer GmbH | HSB | Class II | |
| K090565 | Ellipse Occipito-Cerico-Thoracic Spinal System | Globus Medical, Inc. | KWP | Class II | |
| K090548 | Contra-Angle Handpiece Komet Os30 | W & H DentalWerk Buermoos GmbH | EFB | Class I | |
| K090268 | Shimadzu Mobile X-Ray System Mobile Art Evolution | Shimadzu Corp. | IZL | Class II | |
| K090115 | Retina Camera Trc-Nw7sf Mark II | Topcon Corp. | HKI | Class II | |
| K083583 | Xpresse Injection System | Nordson Efd | FMF | Class II | |
| K082450 | Idr | Icrco, Inc. | MQB | Class II | |
| K091658 | Ge Innova Solid State XRAY-Imager Fluoroscopic X-Ray System, Models Innova 4100, 3100, 2100, 3131, 2121 | GE Healthcare | OWB | Class II | |
| K091598 | Lumencath Applicator Set, Models 189. 795, 189.796, 189.797, 189.798, Lumencath Catheters | Nucletron BV | JAQ | Class II | |
| K091362 | Ceramic Pedatric Preformed Crown | Ez-Pedo, Inc. | ELZ | Class I | |
| K091325 | Ten-Year Fracture Risk Option and Siri Table Option for Norland Dxa Bone Densitometers | CooperSurgical, Inc. | KGI | Class II | |
| K091262 | Mr Cardiac Function Analysis | Ziosoft, Inc. | LLZ | Class II | |
| K091136 | Amsco Evolution Medium Steam Sterilizer, Model Hc-900 and Hc-1200 | STERIS Corporation | FLE | Class II | |
| K091001 | Myrian 1.4 | Intrasense | LLZ | Class II | |
| K090980 | Hd Endoeye, Models Wa50011a, Wa50013a, Wa50013l, Wa50013t, Wa50015l | Olympus Winter & Ibe GmbH | NWB | Class II | |
| K090885 | Nephros, Inc., Dsu Dual Stage Ultrafilter | Nephros Inc | FIP | Class II | |
| K090884 | Perifix One Pediatric Catheter, 20 Ga. & 24 Ga. | B.Braun Medical, Inc. | BSO | Class II | |
| K090560 | Conmed Linvatec Anodized Aluminum Sterilization Trays | Conmed Linvatec | KCT | Class II | |
| K090126 | Fotona Xp Nd: Yag Laser System Family, Fotona Xp, Xp-2 Focus, Fotona Xp Changer,model Moo1-14F, Moo1-14F, Moo1-14F/2, | Fotona D.D. | GEX | Class II | |
| K083640 | Digital X-Ray Imaging System, Model: Cxd-Dr80d | Choong Wae Medical Corp. | KPR | Class II | |
| K080365 | Morce Power Plus and Variocarve Morcellator | Nouvag AG | HET | Class II | |
| K091510 | Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720, M00516730 | Boston Scientific Corporation | ESW | Class II | |
| K091243 | Ortholoc Ankle Plating System (Aps) | Wrightmedicaltechnologyinc | HRS | Class II | |
| K090877 | Proximal Tibia Locking Plate Standard and Large, 3.5Mm Low Profile and Multidirectional Screws | Depuy Orthopaedics Inc. | HRS | Class II | |
| K090865 | Life Spine Facet Screw Spinal System | Life Spine | MRW | Unclassified | |
| K090583 | Endoscopic Monopolar Scissors, Models Ems-235, Ems-165 | Apollo Endosurgery, Inc. | KGE | Class II | |
| K090580 | Thermage Thermacool Nxt System and Accessories | Solta Medical, Inc. | GEI | Class II | |
| K090484 | Alice Pdx | Respironics Inc., Sleep & Home Respiratory Group | MNR | Class II | |
| K090164 | Ceralas Multiwavelength 980/1470Nm Diode Laser | Biolitec, Inc. | GEX | Class II | |
| K083756 | Guardian 150 Electrode | Spectramed, LLC | GXY | Class II | |
| K083435 | Arthrex Univers II Shoulder Pegged Glenoid | Arthrex GmbH | KWS | Class II | |
| K083256 | Ultrasonic Nebulizer System, Model Kn-9210 | K-Jump Health Co., Ltd. | CAF | Class II | |
| K083119 | Portex Tracheal Tube, Sizes 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 | Abbott Medical | BTR | Class II | |
| K091667 | Xtag Respiratory Viral Panel, Models I019a0110, I019c011, I019d0112, I019e0113, S019-0116 | Luminex Molecular Diagnostics Inc | OCC | Class II | |
| K091317 | Lumbofix Conductive Garment, Model 420 Back | Bio-Medical Research, Ltd. | GZJ | Class II | |
| K091225 | Validate Gc1, Gc2, Gc3 and Gc4 Calibration Verification/linearity Test Set | Maine Standards Co. | JJY | Class I | |
| K090976 | Vericore Abutment in Zirconia for Implant Systems | Whip-Mix Corp. | NHA | Class II | |
| K090894 | Collawound Wound Dressing | Collamatrix Co., Inc. | KGN | Unclassified | |
| K090840 | Ventlab 5000 Series Nebulizer Assembly, Cup, Cup W/ Mask, Cup W/ Fitsall Conn. | Salter Labs | CAF | Class II | |
| K090507 | Modification to Ldr Spine Roi Interbody Fusion System; Roi-a Implant System | Ldr Spine USA | MAX | Class II | |
| K083883 | Chartis Catheter | PULMONX, Corp. | CBI | Class II | |
| K083685 | Endovive Low Profile Replacement Gastrostomy Tube, Model 82Xx, 8283, 8284, 8285 | Mri Manufacturing and Research, Inc. | KNT | Class II | |
| K083199 | Chartis Console | PULMONX, Corp. | BZG | Class II | |
| K082068 | E. Coli Pna Fish | Advandx, Inc. | JSS | Class I |