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 |
|---|---|---|---|---|---|
| K893148 | Almatex Exam Gloves (Mfg. Concept Rubber) | Healthgard Medical Products Ltd. Partnership | LYY | Class I | |
| K893131 | Digital Spot Imaging (Dsi) | Philips North America LLC | JAA | Class II | |
| K893010 | Argelite 54+ | Argen Precious Metals, Inc. | EJT | Class II | |
| K892985 | Patient Examination Gloves | Eac Rubber Industries (M) Sdn. Bhd. | LYY | Class I | |
| K892907 | Casting Alloy for Porcelain-Fused-to-Metal Restor. | Deringer-Ney, Inc. | EJT | Class II | |
| K892893 | Sdi Polycarbonate Crown, Schein's | Svenska Dental Instruments AB | ELZ | Class I | |
| K892752 | Patient Exam Gloves (Mfg. Wood Ting Industry) | Foodhandler, Inc. | LYY | Class I | |
| K892701 | Patient Examination Gloves (Latex) | Nature'S Farm Products (Thailand) Co., Ltd. | LYY | Class I | |
| K892460 | Telstar Model Pp Ite Hearing Aid | Telstar Electronics, Inc. | ESD | Class I | |
| K892459 | Telstar Model C Ite Hearing Aid | Telstar Electronics, Inc. | ESD | Class I | |
| K892458 | Telstar Model F Ite Hearing Aid | Telstar Electronics, Inc. | ESD | Class I | |
| K892457 | Telstar Model 1/3 Ite Hearing Aid | Telstar Electronics, Inc. | ESD | Class I | |
| K892150 | Patient Examination Gloves (Latex) | Dmp, Inc. | LYY | Class I | |
| K891879 | Summa Protech: Delta Series Patient Exam Gloves | Summa Intl. | LYY | Class I | |
| K891872 | Patient Examination Gloves (Latex) | Orient Intl. Trading, Inc. | LYY | Class I | |
| K891843 | Rank Patient Exam Gloves (Mfg. Inter-Continental) | Worldwide Medical Corp. | LYY | Class I | |
| K891834 | Nil Patient Examination Gloves (Latex) | Glatex Sdn Bhd | LYY | Class I | |
| K891832 | Patient Examination Gloves (Latex) | Integrasia Sdn Bhd | LYY | Class I | |
| K891830 | Patient Examination Gloves (Latex) | Perindustrian Masmuar Sdn Bhd | LYY | Class I | |
| K891825 | Patient Examination Gloves (Latex) | J & T Medical Products Co., Ltd. | LYY | Class I | |
| K891660 | Prolife Patient Examination Gloves (Latex) | B J L Glove (M) Sdn. Bhd. | LYY | Class I | |
| K891658 | Regent Biogel D(tm) Non-Sterile Dental Gloves | Regent Hospital Products | LYY | Class I | |
| K891466 | Accuspec Thyroid Uptake System | Nuclear Data, Inc. | IZD | Class I | |
| K891421 | Patient Examination Gloves (Latex) | Charone, Inc. | LYY | Class I | |
| K891382 | Ortho Hsv 1&2 Dichromatic Typing Reagent & Slides | Ortho Diagnostic Systems, Inc. | GQL | Class II | |
| K891262 | Kdg Acetabular Component | Osteonics Corp. | LWJ | Class II | |
| K890497 | Model 20-P Extended High Frequency Audiometer | Monitor/Demlar | EWO | Class II | |
| K884991 | Cardiocap Cck-104 Keyboard & Ccp-104 Graphics Prin | Datex Division Instrumentarium Corp. | BSZ | Class II | |
| K884869 | Modified Mrl Neuroprobe System V | Medical Research Laboratories, Inc. | GZJ | Class II | |
| K883159 | Ohmeda 7800 Anesthesia Ventilator | GE Healthcare | CBK | Class II | |
| K893389 | Model Se-5 Epilator | R. A. Fischer Co. Corp. | KCW | Class I | |
| K893173 | Vista Specialist Ophthalmoscope (Battery & Ac) | Keeler Instruments, Inc. | HLI | Class II | |
| K893172 | Vista Ophthalmoscope (Battery and Ac-Powered) | Keeler Instruments, Inc. | HLI | Class II | |
| K893170 | Vista Finoff Transilluminator (Ac-Powered) | Keeler Instruments, Inc. | HJM | Class II | |
| K892445 | Reaads-RF Test Kit-Semiquantitative | Biosearch Medical Products, Inc. | DHR | Class II | |
| K892444 | Reaads-RF Test Kit-Quantitative | Biosearch Medical Products, Inc. | DHR | Class II | |
| K892360 | Water Jel Sterile Gel-Soaked Burn Dressing | Pfizer Inc | FRO | Unclassified | |
| K892067 | Mt9000 Chart Recorder | Astro-Med, Inc. | DSH | Class II | |
| K892065 | Lifepak 250 Defibrillator/monitor | Physio Control, Inc. | MKJ | Class III | |
| K891998 | Bandage, Muslin, Compressed, Camouflaged, 37X37x52 | Elwyn Industries | NAD | Class I | |
| K891908 | Bard(r) Tip Deflecting Electrode Catheter | C.R. Bard Inc | DRF | Class II | |
| K891905 | Cardiovascular Permanent Pacemaker Electrode | Pacesetter Systems | DTB | Class III | |
| K891610 | Henson Cfa 3000 Central Visual Field Screener | Keeler Instruments, Inc. | HOD | Class I | |
| K891238 | Siemens Transesophageal Echo Tee Transducer | Siemens Ultrasound, Inc. | IYN | Class II | |
| K890936 | Alta Hollow Tibial Rods | Howmedica Corp. | HSB | Class II | |
| K885257 | Eagle - Neodyumium Doped Yttrium Aluminum Garnet | Living Technology, Inc. | GEX | Class II | |
| K885170 | Lasercomp Model: 10 Star 10 | Laser-West | GEX | Class II | |
| K884491 | Mediziv Central Vein Catheter | Mediziv Medical Devices, Ltd. | DQY | Class II | |
| K883781 | Nicolet Neuroport/ace System | Nicolet Instrument Corp. | IKN | Class II | |
| K893150 | Plymouth & Lawana Exam Gloves | Healthgard Medical Products Ltd. Partnership | LYY | Class I |