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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K894999 | Latex Patient Examination Gloves | Pushpaman Processors, Div. Kanjur Bleaching Co. PV | LYY | Class I | |
| K894713 | Latex Patient Examination Gloves | Vailwood Products, L.P. | LYY | Class I | |
| K891239 | Mop Catheter | Bivona Medical Technologies | KDL | Class II | |
| K896368 | Modified Axostim | Singer Medical Products, Inc. | BXN | Class II | |
| K896195 | Needle Syringe Disposal Device | Advanced Medical Components, Inc. | MMK | Class II | |
| K896119 | Rms 90/15 Radiographic/fluoroscopic Tilting Table | Rms Div. | IXR | Class II | |
| K896072 | D.l. Scope Ophthalmoscope | North American Medical Products, Inc. | HLJ | Class II | |
| K895491 | Latex Patient Examination Gloves | Big Rubber Co., Ltd. | LYY | Class I | |
| K895446 | Cmi Vacuum Pump W/#101a Vacuum Pump (Auto-Clave.) | Challenge Mfg., Inc. | HDB | Class II | |
| K895410 | Remington Tanfastic Handheld Tanning Wand | Remington Products Company LLC | FTC | Class II | |
| K895375 | Multispiro | Medical Equipment Designs, Inc. | BZG | Class II | |
| K894229 | New Freedom Anyday Pantiliners | Kimberly-Clark Corporation | HHD | Class I | |
| K894168 | Swan-Ganz Therm Cath Sm Heart Amc Throm 93A102h5f | Baxter Healthcare Corporation | DQO | Class II | |
| K893793 | Tenzcare Electrode 6862 | 3M Company | GXY | Class II | |
| K893678 | Duran Flexible Annuloplasty Ring & Obturator H601h | Medtronic Blood Systems, Inc. | KRH | Class II | |
| K893366 | Latex Examination Gloves | Jinshan Caojing Latex Factory | LYY | Class I | |
| K896369 | Titanium Mesh Maxillofacial Implant System | Techmedica, Inc. | EZX | Class II | |
| K896176 | Exusorb(tm) Dry/wet Dressing | Controlled Therapeutics Corp. | KOZ | Class I | |
| K895856 | Medisystems Transducer Protector | Medisystems Corp. | FIB | Class II | |
| K895419 | Disposable Disc Filter | The Medi-Dose Group | FMF | Class II | |
| K895389 | Depuy (Tm) True Compression Screw | Depuy, Inc. | HWC | Class II | |
| K895191 | Anti-Thrombogenic Coating for Catheters | Burron Medical, Inc. | FOZ | Class II | |
| K894961 | Medisonic Ultra-Sonic Inhaler | Medisonic U.S.A., Inc. | CAF | Class II | |
| K896280 | Micro-Aire Oscillating Saw Blade 202C-25, 202C-50 | Micro-Aire Surgical Instruments, Inc. | GFA | Class I | |
| K896266 | Vs22 Hip Prosthesis | 3M Company | KWY | Class II | |
| K896206 | Statspin Statsampler | Statspin Technologies | JKA | Class II | |
| K896165 | Sterile Hypoallergenic Surgeons' Gloves | Isratech Marketing Corp. | KGO | Class I | |
| K896025 | The Shuttle (Tm) Three Wheel Scooter | Pride Health Care, Inc. | INI | Class II | |
| K895441 | Acromed Button Spinal Wire | Acromed Corp. | KWP | Class II | |
| K895439 | Acromed Beaded Sublaminar Wire | Acromed Corp. | KWP | Class II | |
| K895413 | Acromed Double Sublaminar Wire | Acromed Corp. | KWP | Class II | |
| K895378 | Proximal Cement Spacer | Osteonics Reconstructive Products Div. | JDK | Class II | |
| K895359 | Adms Multiplane Rectal Probe | Avalon Technology Corp. | ITX | Class II | |
| K894547 | Radius Cf | General Electric Co. | ITX | Class II | |
| K894016 | Magnetic Resonance Diagnostic Device Mrp-20 | Summit World Trade Corp. | LNH | Class II | |
| K893395 | Mini-Monitor J7000 Icp | Ladd Research Industries, Inc. | GWM | Class II | |
| K896324 | Elite 1500 Radiographic Tilting Table | Rms Div. | IXR | Class II | |
| K896294 | Dsl I-Pth (Dsl #8000) | Diagnostic Systems Laboratories, Inc. | CEW | Class II | |
| K896251 | Hwa Teh Examination Gloves | Hwa Teh Industrial Sdn. Bhd. | LYY | Class I | |
| K896217 | Sas Latex Examination Gloves | SAS Rubber Products Co., Ltd. | LYY | Class I | |
| K895733 | Fibervision(tm) | Fiber Imaging, Inc. | IYE | Class II | |
| K895592 | Freeway Nebulizer Compressor | Lifecare Services, Inc. | CCQ | Class I | |
| K895549 | M.d.i. Adapter | Custom Connection Corp. | BZA | Class I | |
| K895497 | Latex Patient Examination Glove | Plymouth, Ltd. | LYY | Class I | |
| K895177 | Puritan-Bennett Oxygen Concentration Indicator | Medtronic, Inc. | CAW | Class II | |
| K894794 | Agishi Ascites Pump Peritoneocaval Shunt Pump | Vitaid, Ltd. | KPM | Class II | |
| K894751 | Caribbean Latex Products Examination Gloves | Caribbean Latex Products, Inc. | LYY | Class I | |
| K894381 | Gammamed Iridium-192 Source | Mick Radio-Nuclear Instruments, Inc. | JAQ | Class II | |
| K894061 | Studio Uno | Eurodent, Inc. | EIA | Class I | |
| K893937 | Latex Examination Gloves | Sai Latex Private, Ltd. | LYY | Class I |