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 |
|---|---|---|---|---|---|
| K870744 | Surgical Starter Kit | Devon Industries, Inc. | |||
| K870689 | Hr-3000 Reuse Adaptor | Colorado Medical, Inc. | LIF | Class II | |
| K870622 | Heart*aid 1000 | Cardiac Resucitator Corp. | MKJ | Class III | |
| K870606 | Tonomitor(tm) | Tonometrics Holdings SA C/O Mackeen Consultants | FFT | Class I | |
| K870531 | Ez Tac Filter | John F. Greer Co., Inc. | EXB | Class I | |
| K870517 | 0.1Mm, 0.25Mm, 0.5Mm, Zoom Dermatologic Handpiece | Coherent Medical Group | GEX | Class II | |
| K870471 | Modified Hr-3000 Reuse Adaptor | Colorado Medical, Inc. | LIF | Class II | |
| K870263 | Neuromapper 1620 | Neuroscience, Inc. | GWQ | Class II | |
| K870119 | Fibre Optic Strip Chart Recorder | Apex Imaging Corp. | DSF | Class I | |
| K870118 | Model 6110B Dentaphor | Life-Tech Intl., Inc. | EAT | Class II | |
| K864887 | Advanced Hand Held CO2 Laser Model Hh-550 for Su | Bio Quantum Technologies, Inc. | GEX | Class II | |
| K864833 | Pos-T-Vac | Ekc, Inc. | LKY | Class II | |
| K864370 | Dynatron 1120 Eps (Electrical Point Stimulator) | Dynatronics Laser Corp. | GZJ | Class II | |
| K862045 | Doc's Proplugs Ear Plugs | Doc'S Proplugs, Inc. | EWD | Unclassified | |
| K861505 | Hipec Analyzer - Ha 100 Hi-Pro Multi-ECG Analyzer | American Medical Equipment, Inc. | DXG | Class II | |
| K870907 | Introducer, Percutaneous | Med Fusion Systems, Inc. | DYB | Class II | |
| K870880 | Ek10 Electrocardiograph | Burdick Corp. | DPS | Class II | |
| K870729 | Titanium Percutaneous Greenfield Vena Cave Filter | Medi-Tech, Inc. | DTK | Class II | |
| K870675 | Additional 13.4Cm. French Catheter Insertion Tray | Quinton, Inc. | DQY | Class II | |
| K864818 | Ackrad Tdi Set | Ackrad Laboratories | KRB | Class II | |
| K864563 | Model Ls 840, CO2 Laser | Cooper Lasersonics, Inc. | GEX | Class II | |
| K864562 | Model Ls 860, CO2 Laser | Cooper Lasersonics, Inc. | GEX | Class II | |
| K864504 | Q5000 Stress Test Monitor | Quinton, Inc. | DPS | Class II | |
| K864118 | Medi-Tech Selective Torque Catheter | Medi-Tech, Inc. | DQY | Class II | |
| K871286 | Gram Iodine | Remel Inc | HYI | Class I | |
| K871284 | Flow Pac Total Iron Reagents:2183,2349,2312,014339 | American Research Products Co. | JIY | Class I | |
| K871279 | Modified Trichomonas Direct Specimen Test Kit | California Integrated Diagnostics, Inc. | JWZ | Class I | |
| K871278 | Modified Chlamydia Direct Specimen Test Kit | California Integrated Diagnostics, Inc. | LJP | Class I | |
| K871083 | Cm 5000 Monitor Airway Pressure | Canadian Monaghan, Ltd. | CAP | Class II | |
| K870963 | Modified Pathfinder Specimen Collection Kit | Kallestad Diag, A Div. of Erbamont, Inc. | LIO | Class I | |
| K870580 | Mlc Normal Serum | Rjo Biologicals, Inc. | KIS | Class I | |
| K870521 | Tandem(r) M-Pak(tm) Total B-Hcg Immunoenzy. Assay | Hybritech, Inc. | JHI | Class II | |
| K870450 | Szac-16 Seizure Analysis Computer | Grass-Telefactor Product Group | OMB | Class II | |
| K871225 | Hand Surgery Table Extension | Mizuho Orthopedic Systems Inc | FWZ | Class I | |
| K871205 | Custom in-the-Ear Hearing Aid | Audiological Services, Inc. | ESD | Class I | |
| K871122 | Triglycerides Determination | Biochemical Trade, Inc. | CDT | Class I | |
| K864720 | Light-Cured Periodontal Dressing | Dentsply Intl. | EMA | Class II | |
| K864376 | Fiberbond | Dentec, Inc. | DYT | Class I | |
| K863481 | Modification of Accu-Chek II | Boehringer Mannheim Corp. | CGA | Class II | |
| K871215 | Disposable Shadow Tray Inserts | Mick Radio-Nuclear Instruments, Inc. | IWB | Class II | |
| K871195 | Mallet, Bone Surgery, Stainless Steel, 2Lb. | Military Engineering, Inc. | HXL | Class I | |
| K871168 | Instant Cold Compress, Chemical Type | Lexington Industries | IMD | Class I | |
| K871118 | Modified Townley Unicondylar Knee | Depuy, Inc. | KYK | Class II | |
| K871069 | Modified Hysterosalpingograpy Set | Ackrad Laboratories | KNA | Class II | |
| K871058 | Serachem Liquid Spinal Fluid Control (Human) | Fisher Scientific Company L.L.C. | JJY | Class I | |
| K870939 | Vibracare | General Physiotherapy, Inc. | ISA | Class I | |
| K870743 | Hercon Anti. Trans. Dressing as a Wound Dressing | Hercon Laboratories Corp. | FRO | Unclassified | |
| K870684 | Liquid Chemistry Control, Level I | U. S. Diagnostics, Inc. | JJY | Class I | |
| K870683 | Liquid Chemistry Control, Level II | U. S. Diagnostics, Inc. | JJY | Class I | |
| K870671 | Phacotron Day Pak | United Surgical LLC | HQC | Class II |