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 |
|---|---|---|---|---|---|
| K002860 | Model 6900Ge-64: C-Spine Array | Midwest Rf, LLC | MOS | Class II | |
| K002816 | Transonic Hemodialysis Flow Reverser, Model B Flowrev | Transonic Systems Inc | KOC | Class II | |
| K002778 | Enteric Injection Catheter with Irrigation | Enteric Medical Technologies | FBK | Class II | |
| K002683 | Wmt Ultra-Fit Modular Shoulder System | Wrightmedicaltechnologyinc | KWS | Class II | |
| K002672 | Vypro Mesh, Vicryl Prolene Partially Absorbable Synthetic Surgical Mesh | Ethicon, Inc | FTL | Class II | |
| K002598 | Emerson Cough Assist Model Ca-3000 W/automatic Timing and Model Cm-3000 W/manual Timing | J. H. Emerson Co. | NHJ | Class II | |
| K002587 | Branan Medical Corporation Monitect Methamphetamine 500 Drug Screen Test | Branan Medical Corp. | DJC | Class II | |
| K002418 | Branan Medical Corporation Monitect Morphine 300 Drug Screen Test, Model 133C and 133D | Branan Medical Corp. | DOE | Class II | |
| K002417 | Branan Medical Corporation Monitect Methadone Drug Screen Test, Model 190C and 190D | Branan Medical Corp. | DJR | Class II | |
| K002337 | Branan Medical Corporation Monitect Barbiturates Drug Screen Test | Branan Medical Corp. | DIS | Class II | |
| K002272 | Branan Medical Corporation Monitect Pcp Drug Screen Test, Model 160C and 160D | Branan Medical Corp. | LCM | Unclassified | |
| K002266 | Branan Medical Corporation Monitect Amphetamine Drug Screen Test | Branan Medical Corp. | DKZ | Class II | |
| K002047 | Drg Puretone Stethoscope with Drg Antimicrobial, Stethoscope Diaphragm, Model Pt2b27(cardiology), Pt3b27(classic), Pt5b2 | Doctor'S Research Group, Inc. | DQD | Class II | |
| K002024 | Panbio Indx Igm Dip-S-Ticks Leptospirosis Test for the Detection of Igm Antibodies to Leptospira Biflexa | Panbio Limited | GRY | Class II | |
| K001947 | T.i.m.s., Version 2.00 | Total Medical Information Management Systems, Inc. | LLZ | Class II | |
| K001651 | Bio-Rad %Cdt Tia | Axis-Shield Biochemicals, ASA | JJX | Class I | |
| K001613 | Comfit Chemo Plus Plus Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) | WRP Asia Pacific Sdn Bhd | LZA | Class I | |
| K001600 | <Genx> Coda Incubator Cellmate | <Genx> Intl., Inc. | MQG | Class II | |
| K001563 | Scipro(tm) Flexible Stone Dislodger and Retrieval Set | Scion Cardiovascular, Inc. | FGO | Class II | |
| K001520 | Alpha Omega Dual Cooler-Heater | Alpha Omega, Ltd. | DWC | Class II | |
| K000404 | Pc ECG 1200 | Norav Medical Ltd. | MWI | Class II | |
| K003444 | Model Ws-500 Digital Wrist Blood Pressure Monitor | Nihon Seimitsu Sokki Co., Ltd. | DXN | Class II | |
| K003424 | Pinnacle R/o II or Radifocus Introducer II | Terumo Medical Corp. | DYB | Class II | |
| K003317 | Renew Ls-1 | Bisco Inc | EBF | Class II | |
| K003298 | Mo-202U Three-Axis Joystick Hydraulic Micromanipulator | Narishige Co., Ltd. | MQJ | Class II | |
| K003146 | Cliniflo Incentive Spirometer | Dhd Healthcare Corp. | BWF | Class II | |
| K003109 | Complete Brand Lubricating and Rewetting Drops | Allergan | LPN | Class II | |
| K003079 | Specialty Tint Soft Contact Lens | Specialty Tint | LPL | Class II | |
| K002961 | Minitub Multi-Purpose Cassettes | Zander Medical Supplies, Inc. | MQG | Class II | |
| K002864 | Model 6600Ge-64: Trama Neck Array | Midwest Rf, LLC | MOS | Class II | |
| K002813 | Nipro Safetouch Safety Fistula Needle | Nipro Medical Corporation | FIE | Class II | |
| K002806 | K-Defib/pace, Model Kdp-60A | Katecho LLC | MKJ | Class III | |
| K002725 | Micropaq, Models 402 and 404 | Protocol Systems, Inc. | DRT | Class II | |
| K002703 | O-Perm 30 | Optical Polymer Research, Inc. | HQD | Class II | |
| K002649 | Aramis Dermatological Laser | Palomar Medical Technologies, Inc. | GEX | Class II | |
| K002633 | Silmax Pectoral Implant | Pillar Surgical, Inc. | MIC | Class II | |
| K002630 | Puresperm Wash | Nidacon International AB | MQL | Class II | |
| K002214 | Sinuscope and Baccessories | Pollux Endoscopy, Inc. | EOB | Class II | |
| K002089 | Rosetta-Lt/rosetta-Rx | General Devices | DRG | Class II | |
| K003471 | Magna Tek Esu-400 | Huttinger Medizintechnik GmbH & CO KG | GEI | Class II | |
| K003184 | Rs Biotech Galaxy 'R' CO2 Incubator | Zander Medical Supplies, Inc. | MQG | Class II | |
| K003098 | Access Ultrasensitive Hgh Calibrators | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K002752 | Bayonet Forceps Bipolar Irrigating | Q2 Medical | GEI | Class II | |
| K002731 | N Latex B2-Microglobulin | Siemens Healthcare Diagnostics Inc. | JZG | Class II | |
| K002644 | Radial Head Implant | Avanta Orthopaedics, Inc. | KWI | Class II | |
| K002629 | Silmax Contour Carving Block Implant | Pillar Surgical, Inc. | JOF | Class II | |
| K002623 | Puresperm 40 and Puresperm 80 | Nidacon International AB | MQL | Class II | |
| K002605 | 4.0/2.5 Mm Self-Drilling Schanz Screw | Synthes (USA) Products LLC | JDW | Class II | |
| K002199 | Modification to Liquid Glucose (Hexokinase) Reagent Set | Horiba Instruments Incorporated | CFR | Class II | |
| DEN000010 | Triage B-Type Natriuretic Peptide (Bnp) Test | Biosite Incorporated | NBC | Class II |