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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K842442 | Axiom Stable II Uric Acid Test | Axiom, Inc. | KNK | Class I | |
| K842393 | Boehringer Mannheim Diag. Blood Glucose | Boehringer Mannheim Corp. | CGA | Class II | |
| K842365 | Corti-Cote Cortisol Solid Phase Radio | BD Becton Dickinson Vacutainer Systems Preanalytic | CGR | Class II | |
| K842280 | Tdx Digitoxin | Abbott Medical | LFM | Class II | |
| K842159 | Creatinine Assay Kit-Kinetic or Endpoint | Diagnostic Chemicals, Ltd. (USA) | CGX | Class II | |
| K842140 | Picoscal Blood Cell Counter Ps-4 | Diagnostic Technology, Inc. | GKL | Class II | |
| K840904 | Accu-Cult Fecal Occult Blood Test | Applied Medical Devices, Inc. | KHE | Class II | |
| K840845 | Hollow Fiber Dialyzers | Travenol Laboratories, S.A. | KOC | Class II | |
| K843036 | Patient Breathing Circuit | Infrasonics Corp. | BZO | Class I | |
| K842912 | The Suturer | Vlm Surgical, Inc. | |||
| K842865 | Esophageal Stethoscope | Inmed Corp. | BZW | Class I | |
| K842828 | Streptex Zl01 | Wellcome Diagnostics | JTO | Class I | |
| K842787 | Sunbed | Sun Health Systems | FTC | Class II | |
| K842753 | Oxygen Concentrator | Bv Medical Equipment Co. | CAW | Class II | |
| K842742 | Giemsa Stain | E K Ind., Inc. | HYF | Class I | |
| K842741 | Gill Hematoxylin Stain | E K Ind., Inc. | HYJ | Class I | |
| K842572 | Gauze & Lab Sponges Sterile & Non | Ulti-Med Intl., Inc. | GDY | Class I | |
| K842567 | Portable Acuiometer | Randwal Instrument Co., Inc. | HLJ | Class II | |
| K842459 | Site Gills Style I/a Handpiece | Chiron Vision Corp. | |||
| K842458 | Site Simcoe Style I/a Handpiece | Chiron Vision Corp. | HQC | Class II | |
| K842452 | Wako Ldh Cii Test | FUJIFILM Healthcare Americas Corporation | CFH | Class II | |
| K842405 | Dr. Gould Hand Pack Sustom Steril | Pro-Lab, Inc. | FRG | Class II | |
| K842387 | Aca Benzodiazepines Screen Test Pk | E.I. Dupont de Nemours & Co., Inc. | JXM | Class II | |
| K842386 | Aca Barbiturates Screen/benzodiazepin | E.I. Dupont de Nemours & Co., Inc. | DKB | Class II | |
| K842320 | Tdx Rea Cholesterol | Abbott Medical | CHH | Class I | |
| K842251 | Ameri. Medical Optics Argon Laser Photo | American Medical Optics | HQF | Class II | |
| K842250 | Amer. Medical Optics Argon/krypton Lase | American Medical Optics | HQF | Class II | |
| K842249 | Acth Normal Range | Diagnostic Systems Laboratories, Inc. | CKG | Class II | |
| K842237 | Clinitek 200 Semi-Automated Urinalysis | Miles Laboratories, Inc. | KQO | Class I | |
| K842064 | Acu-Derm Transparent IV Dressing | Acme United Corp. | KMK | Class I | |
| K841980 | Side Cutting Serrated Blade | Stainless Mfg., Inc. | HTZ | Class I | |
| K841574 | Quazar Esophageal Stethoscope | Axiom Medical, Inc. | BZW | Class I | |
| K841294 | Acu220 Cryo Unit | Keller Instruments, Inc. | HQA | Class II | |
| K840414 | Color Optic Corneal Eye Shield | Diversations, Inc. | HOY | Class I | |
| K843044 | Minim. Essential Med. Eagle M4144 W/ | Sigma Chemical Co. | KIT | Class I | |
| K843043 | Med. 199 Catalog M3769 W/earle's Salt | Sigma Chemical Co. | KIT | Class I | |
| K842841 | Vivonex Tung Sten Tip Tube | Norwich Eaton Pharmaceuticals, Inc. | KNT | Class II | |
| K842820 | Arthroscopy Knives | Medtech Industries, Inc. | HTS | Class I | |
| K842819 | Hook Punch Forceps for Arthroscopy | Medtech Industries, Inc. | HTD | Class I | |
| K842589 | Ivac Keofeed Hydrophilic Feeding Tube | Y | KNT | Class II | |
| K842275 | Ultrasonic Cool Spray Humidifier | Sunbeam Corp. | KFZ | Class I | |
| K842264 | Ventrezyme Phenobarbital Kit Immuno | Ventrex Laboratories, Inc. | DLZ | Class II | |
| K842076 | Mic Gastrostomy Tube | Medical Innovations, Inc. | KNT | Class II | |
| K841935 | Rionet Hearing Aid Hi-03 | Rion Acoustic Instruments, Inc. | ESD | Class I | |
| K841898 | First Response Emerg. Medicsl - Burns | Reed Products, Inc. | FPY | Class I | |
| K841549 | Hemoclip Automatic Clips Medium | Edward Weck, Inc. | FZP | Class II | |
| K841548 | Hemoclip Ligating Clips M/large | Edward Weck, Inc. | FZP | Class II | |
| K841547 | Hemoclip Ligating Clips Med/sml | Edward Weck, Inc. | FZP | Class II | |
| K840948 | Clear Porous Plastic-Hypoallergenic | Gainor Medical | GKX | Class II | |
| K843045 | Lactalbumin Hydrolysate Med. Catalog | Sigma Chemical Co. | KIT | Class I |