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 |
|---|---|---|---|---|---|
| K944179 | Control III Disinfectant Germicide | Maril Products, Inc. | LRJ | Class I | |
| K944037 | Diacide Hd Disinfecting Solution | Gulfstream Medical | LRJ | Class I | |
| K943660 | Phlebotomy Sharps Disposal Containers | Sage Products LLC | MMK | Class II | |
| K943659 | Ancillary and Large Volume Sharps Disposal Containers | Sage Products LLC | MMK | Class II | |
| K943658 | Chemotherapy Waste Disposal Containers | Sage Products LLC | MMK | Class II | |
| K943649 | Gertie Marx Needle | Argon Medical Devices, Inc | BSP | Class II | |
| K943593 | Saratoga Modular Miniature Endoscope System | Ovamed Corp. | ODF | Class II | |
| K943349 | Mahurkar Dual Lumen Catheter | Quinton, Inc. | FOZ | Class II | |
| K940383 | Lysol I.c. Brand Instrument Disinfectant Presoak | National Laboratories | LRJ | Class I | |
| K932070 | Duracon Stabilizer Femoral Component and Insert | Howmedica Corp. | JWH | Class II | |
| K950976 | Karl Storz Adult and Pediatric Viscous Fluid Injection Sets | Karl Storz Endoscopy-America, Inc. | FBK | Class II | |
| K950927 | Hapex Malleable Torp | Smith & Nephew Richards, Inc. | ETA | Class II | |
| K950912 | Mega-Sil a-B | Microsonic, Inc. | ESD | Class I | |
| K950888 | Screening Audiometry Word Recognition Audiometry | Calmed Technology, Inc. | EWO | Class II | |
| K950818 | Horizon 55 Bi-Con Toric | Westcon Contact Lens Co., Inc. | LPL | Class II | |
| K950758 | Dyna 231X | Phonak, Inc. | ESD | Class I | |
| K950637 | Maico in-the-Ear Model Rd-312 Cic | Maico Hearing Instruments, Inc. | ESD | Class I | |
| K950541 | Howmedica V40 22Mm Femoral Head | Howmedica Corp. | LWJ | Class II | |
| K950451 | M-29 Pp-Pc, M-29 Pp-O/pc | Rexton, Inc. | ESD | Class I | |
| K950427 | Urine Benzodiazepines Screen Flex Teagent Cartridge | E.I. Dupont de Nemours & Co., Inc. | JXM | Class II | |
| K950369 | Visualine II Cocaine | Sun Biomedical Laboratories, Inc. | DIO | Class II | |
| K950246 | Multiple (Izon Urine Collection Kit) | Izon Business Products, Inc. | JXA | Class I | |
| K950221 | Multiple (Izon Blood & Urine Collection Kit) | Izon Business Products, Inc. | JXA | Class I | |
| K950182 | Urine Methadone Screen Flex(tm) Reagent Cartridge | E.I. Dupont de Nemours & Co., Inc. | DIW | Class II | |
| K950134 | Urine Cocaine Metabolite Screen Flex(tm) Reagent Catridge | E.I. Dupont de Nemours & Co., Inc. | DLN | Class II | |
| K950104 | Elx800 and El800 Automated Microplate Readers | Bio-Tek Instruments, Inc. | JJQ | Class I | |
| K950101 | Rams (Random Access Mass Spectrometer) M-200 Respiratory Gas Monitor | Marquette Electronics, Inc. | CBS | Class II | |
| K950041 | Sii 360 Apr | Scott Imaging Intl., Inc. | IZO | Class I | |
| K950040 | Sii 525 Apr | Scott Imaging Intl., Inc. | IZO | Class I | |
| K950028 | Primidone Fpia Reagent Set and Calibrators | Sigma Diagnostics, Inc. | LFT | Class II | |
| K946116 | Uristrip Reagent Strips Test for Protein, Glucose, Ph and Blood | Chemtech Labs, Inc. | JIL | Class II | |
| K945982 | Karl Storz Take-Apart(r) Suture Forceps, Knot Tier | Karl Storz Endoscopy-America, Inc. | HET | Class II | |
| K945858 | X-Ray Film Cassette | J.P.I. Chicago Co. | IXA | Class II | |
| K945806 | Silicath All Silicone Foley Catheter | Unomedical Sdn Bhd | EZL | Class II | |
| K945453 | Ud 150L-R II | Shimadzu Medical Systems | IZO | Class I | |
| K945452 | Ud 150L-F | Shimadzu Medical Systems | IZO | Class I | |
| K945386 | Stratis | FUJIFILM Healthcare Americas Corporation | LNH | Class II | |
| K945261 | Prism 1500Xp Nuclear Gamma Camera System | Ohio Imaging, Inc. | KPS | Class II | |
| K945037 | Siemens 1481 T Transmitter, Enhanced | Siemens Medical Solutions USA, Inc. | DRG | Class II | |
| K944698 | Auraflex Prolactin 200 Test Pack, Calibrator Pack, Dilvent 1 | bioMerieux, Inc. | CFT | Class I | |
| K944525 | Liquid Assayed Tumor Marker Control Level 1, Level 2, Level 3 | Medical Analysis Systems, Inc. | JJY | Class I | |
| K943990 | 3000 Aerosol Two | Medical Industries America, Inc. | CAF | Class II | |
| K943599 | Chem Trak Accumeter | Chemtrak, Inc. | CHH | Class I | |
| K943518 | Sta System Control [N] + [P] Kit | American Bioproducts Co. | GGN | Class II | |
| K943053 | Ksea Semm Tissur Punch | Karl Storz Endoskop GmbH | HET | Class II | |
| K942986 | Electrodes (Blade, Ball, Needle, and Loop) | Apyx Medical Corporation | HGI | Class II | |
| K941210 | Ptt-Lt Test Kit | American Bioproducts Co. | GGW | Class II | |
| K935383 | Femrod and Femrod Recon Insert | Applied Osteo Systems, Inc. | HSB | Class II | |
| K932779 | Birtcher Swivel Grip Laparoscopic Probes & Access. | Birtcher Medical Systems, Inc. | HET | Class II | |
| K932055 | Percupump II | E-Z-EM, Inc | FIH | Class II |