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 |
|---|---|---|---|---|---|
| K892064 | Latex Surgical Gloves,sterile/non Sterile Mod Bran | Modern Rubber Industrial Co., Ltd. | KGO | Class I | |
| K892057 | Ohmeda Tec 5 Continuous Flow Vaporizer | GE Healthcare | CAD | Class II | |
| K891970 | Patient Examination Gloves (Latex) | Golden Hit, Ltd. | LYY | Class I | |
| K891969 | Patient Examination Gloves (Latex) | Protective Glove Co. | LYY | Class I | |
| K891846 | Patient Examination Gloves (Latex) | Shing Shuenn Co., Ltd. | LYY | Class I | |
| K891801 | Patient Examination Gloves (Latex) | Taiwan Link Sdn Bhd | LYY | Class I | |
| K891799 | Patient Examination Gloves (Vinyl) | Tak Ent., Inc. | LYZ | Class I | |
| K891798 | Patient Examination Gloves (Latex) | Li-Fa Chemical Industry Co., Ltd. | LYY | Class I | |
| K891795 | Disposable Latex Exam Gloves | Eagle Medical, Inc. | LYY | Class I | |
| K891738 | Perfect Touch Patient Exam Gloves (Latex) | Young Innovations, LLC dba Plak Smacker | LYY | Class I | |
| K891732 | Thaisan Gloves (Patient Exam Gloves - Latex) | Thaisan Industries Co., Ltd. | LYY | Class I | |
| K891718 | Latex Examination Gloves | Liu'S Glove Corp. | LYY | Class I | |
| K891711 | Patient Examination Gloves (Latex) | E-Full Industrial, Ltd. | LYY | Class I | |
| K891710 | Patient Examination Gloves (Latex) | Klh Medical, Inc. | LYY | Class I | |
| K891709 | Latex Examination Gloves, Non-Sterile | Taiwan David, Inc. | LYY | Class I | |
| K891673 | Advanced Purification Glass Column | Waters Chemical Products | DPM | Class I | |
| K891659 | Wise & Safe Patient Examination Gloves (Latex) | Wise Industries Sdn. Bhd. | LYY | Class I | |
| K891506 | Freepinho Vinyl Exam Gloves | Reliance Industrial Co., Ltd. | LYZ | Class I | |
| K891478 | Dsl 7900 Active Dhea-S (Dsl #7900) | Diagnostic Systems Laboratories, Inc. | JKC | Class I | |
| K891448 | Patient Examination Gloves (Latex) | Naturalex Rubber Products (M) Sdn Bhd | LYY | Class I | |
| K891441 | Non-Sterile Latex Examination Gloves | Arista Latindo Industrial, Ltd. P.T. | LYY | Class I | |
| K891426 | Proshield Glove (Latex) | K & M Resources, Inc. | LYY | Class I | |
| K891365 | Latex Examination Gloves, Non-Sterile | China National Medicines & Health Prod. I/E Corp. | LYY | Class I | |
| K891308 | Sterile Surgical Gloves | Carl Parker Associates, Inc. | KGO | Class I | |
| K891305 | Patient Examination Gloves (Vinyl) | B & L Ent. Co. | LYY | Class I | |
| K891304 | Patient Examination Gloves (Latex) | B & L Ent. Co. | LYY | Class I | |
| K891272 | 'Quest', 'Pelangi' Patient Exam Gloves (Latex) | Pelangi Rubber Products Sdn. Bhd. | LYY | Class I | |
| K891261 | Intraoperative Radiation Therapy Devices | General Electric Co. | LHN | Class II | |
| K891223 | Patient Examination Gloves (Latex) | Sin Super Holdings Sdn Bhd | LYY | Class I | |
| K891094 | Aca(r) Digitoxin (Dgtx) Method | E.I. Dupont de Nemours & Co., Inc. | LFM | Class II | |
| K891093 | Aca (R) Digitoxin Calibrator | E.I. Dupont de Nemours & Co., Inc. | DCJ | Class I | |
| K890907 | Royal Shield Latex Examination Gloves(tm) | Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. | LYY | Class I | |
| K890837 | Ria-Gnost Insulin | Cambridge Medical Technology | CFP | Class I | |
| K890716 | Luxtec Aco Series 4000 Light Source | Luxtec Corp. | FCW | Class II | |
| K890468 | Model Ft-100 Intracranial Pressure Monitor | Pearl Instruments Corp. | GWM | Class II | |
| K890344 | Gloves, Patient Examination | Tomarc (M) Sdn Bhd | JTN | Class II | |
| K890267 | Quikread Chem. Analyzer & Choles. for Serum/plasma | Photec Diagnostics, Inc. | CHH | Class I | |
| K890176 | Extension Sets with and without Filters | Medical Support Systems | FPA | Class II | |
| K890027 | Quikread Chem. Analyzer & Choles. for Whole Blood | Photec Diagnostics, Inc. | CHH | Class I | |
| K885276 | Model L-2000 & L-500 Chiropractic Tables | Lesarn Mfg., Ltd. | INQ | Class I | |
| K885190 | Micro-Stim 200 | Theri-Teck, Inc. | GZJ | Class II | |
| K885055 | Insu Cool | Dynex Trading Co. | LDQ | ||
| K885020 | Cytoguide | Philips North America LLC | IZH | Class II | |
| K884803 | Aerochamber M.v. | Monaghan Medical Corp. | CAF | Class II | |
| K884786 | Ear Irrigation Set 101 (Earigator) | Physicians Supply Co. | KYZ | Class I | |
| K884621 | Digiscan | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K884563 | Oxygen Concentrator W/concentration 3Lpm 93% +/-3% | Ivex Medical, Inc. | CAW | Class II | |
| K884328 | Choice Also Orient Surgical Gloves (Sterile) | Select Sources, Inc. | KGO | Class I | |
| K884163 | Acromed Spinal Rod and Spinal Hooks | Buckman Co., Inc. | KWP | Class II | |
| K884117 | Type 9210 ECG System Athena | S & W Medico Teknik | DRT | Class II |