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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K181849 | iStim S2 OTC Pain Relief TENS | Everyway Medical Instruments Co., Ldt. | NUH | Class II | |
| K181627 | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner | Bausch & Lomb Incorporated | MRC | Class II | |
| K181584 | Redi-Spine | Innovative Surgical Designs, Inc. | NKB | Class II | |
| K181253 | Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup | Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC | OAP | Class II | |
| K181151 | GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System | Ethicon, Inc | PWJ | Class II | |
| K181130 | Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs | Hebei Titans Hongsen Medical Technology Co.,Ltd | LZC | Class I | |
| K180834 | Altrix Precision Temperature Management System | Stryker Medical | DWJ | Class II | |
| K180814 | CoreLink® M3™ Stand-Alone Anterior Lumbar System | Corelink, LLC | OVD | Class II | |
| K180644 | Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green | Hartalega Sdn Bhd | LZA | Class I | |
| K180234 | physiQ Heart Rhythm Module | Physiq, Inc. | DPS | Class II | |
| K170110 | Diana Medication Transfer Set | Abbott Medical | ONB | Class II | |
| DEN170052 | Natural Cycles | Natural Cycles Nordic AB | PYT | Class II | |
| K181866 | MotoCLIP/HiMAX Step Staple Implant System | Crossroads Extremity Systems LLC | JDR | Class II | |
| K181680 | ICONN Answer II Suture Anchor | Iconn Orthopedics, LLC | MBI | Class II | |
| K181677 | Kodiak Spinal Fixation System | Alphatec Spine, Inc. | NKB | Class II | |
| K181557 | INFINITY Total Ankle System | Wrightmedicaltechnologyinc | HSN | Class II | |
| K181544 | Anchor Bolt (as an accessory to Depth Electrodes) | AD-Tech Medical Instrument Corp. | GZL | Class II | |
| K181533 | EVOS Wrist Fracture Plating System | Smith & Nephew, Inc. | HRS | Class II | |
| K181430 | LENSAR Laser System - fs 3D (LLS-fs 3D) | LENSAR, Inc | OOE | Class II | |
| K180759 | SECULOK™ Suture Anchor | CG MedTech Co., Ltd. | MBI | Class II | |
| K180417 | Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use | Berpu Medical Technology Co., Ltd. | MEG | Class II | |
| K173844 | Titan Ag 200 | Specialty Fibres and Materials, Ltd. | FRO | Unclassified | |
| K173819 | MyPlant II Implant System | Hager & Meisinger GmbH | DZE | Class II | |
| K173505 | FORA GTel Blood Glucose Monitoring System | Foracare, Inc. | NBW | Class II | |
| K173407 | Vt - 100, Vt - 200 | Carilex Medical, Inc. | OMP | Class II | |
| K171245 | Presygen/si-1 | Christie Medical Holdings, Inc. | MUD | Class II | |
| K181946 | Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL | Thermo Fisher Scientific Oy | JWY | Class II | |
| K181853 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader | Alere Scarborough, Inc. | PSZ | Class II | |
| K181836 | 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters | Cordis, A Cardinal Health Company | DQO | Class II | |
| K181041 | 7D Surgical System Cranial Application | 7D Surgical, Inc. | HAW | Class II | |
| K180805 | Pure EP | Biosig Technologies | DQK | Class II | |
| K180734 | SmartLinx Vitals Plus Patient Monitoring System | Capsule Technologie | MWI | Class II | |
| K180598 | UNIQA Dental Implants System | Uniqa Dental Ltd | DZE | Class II | |
| K180221 | Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs | Smart Glove Corporation Sdn. Bhd. | KGO | Class I | |
| K180169 | EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length | Imperative Care Inc. | DQY | Class II | |
| K173193 | F&P SleepStyle | Fisher & Paykel Healthcare, Inc. | BZD | Class II | |
| K172508 | Ageless Health Medical Digital Thermometer | Ageless Health Industrial Co., Ltd. | FLL | Class II | |
| K181962 | CubeVue | CurveBeam, LLC | LLZ | Class II | |
| K181828 | Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile | Scientia Vascular | MOF | Class II | |
| K181234 | Self-adhesive Electrode | Dong Guan OU Kang Electronics Co.,Ltd | GXY | Class II | |
| K181218 | AlignRT Plus | Vision Rt Inc | IYE | Class II | |
| K180634 | Surgical Silver Post Operative Dressing | Advanced Medical Solutions Limited | FRO | Unclassified | |
| K180351 | EndoWrist Mercury Bipolar Grasper | Intuitive Surgical, Inc. | NAY | Class II | |
| K180248 | VascuEase IC-1200-WH | Bio Compression Systems, Inc. | JOW | Class II | |
| K173848 | Model WP-3840 and WP-3040 | Cnmc Co., Inc. | IYE | Class II | |
| K181346 | CystoSure Plus Catheter | Emmy Medical, LLC | EZL | Class II | |
| K180853 | EP Granules™ BVF | Elute, Inc. | MQV | Class II | |
| K180075 | MINUET LCD, MINUET LCD eco | Unimom.Co | HGX | Class II | |
| K173845 | Arthrex SwiveLock | Arthrex GmbH | MBI | Class II | |
| K181425 | APTUS® Proximal Humerus System | Medartis AG | HRS | Class II |