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 |
|---|---|---|---|---|---|
| K894214 | Rubber Tree Brand | Jinmei International, Inc. | LYY | Class I | |
| K894126 | Robotic Sample Processor | Tecan U.S. | JQW | Class I | |
| K894122 | Leeco Vis-Disk Strep-a (Eia) | Leeco Diagnostics, Inc. | GTZ | Class I | |
| K893985 | Hgb-Control Set/multiple | R & D Systems, Inc. | GGM | Class II | |
| K893984 | Hgb-Cal Set/multiple | R & D Systems, Inc. | KRZ | Class II | |
| K893977 | Gram Negative and Positive Mic/combo Panels | Baxter Healthcare Corporation | JWY | Class II | |
| K893953 | Absolute(tm)-Hcg Urine Pregnancy Test | Totem Diagnostics, Inc. | DHA | Class II | |
| K893944 | Fd 300 Dental Stool | Oriola OY Finndent | KLC | Class I | |
| K893943 | Fd 200 Dental Stool | Oriola OY Finndent | KLC | Class I | |
| K893890 | Fd4500 (Dental Chair) | Oriola OY Finndent | KLC | Class I | |
| K893889 | Fd3500 (Dental Chair) | Oriola OY Finndent | KLC | Class I | |
| K893808 | Model 0450000, Opal Medical Exam Light | Burton Medical Products Corp. | KZF | Class I | |
| K893807 | Model 0183010, Pearl Medical Exam Light | Burton Medical Products Corp. | KZF | Class I | |
| K893768 | Modified Pk300 Automatic Eia Analyzer | Olympus Corp. | JJF | Class I | |
| K893764 | Sterilization Tray Liner | Ahlstrom Dexter | FRG | Class II | |
| K893583 | Beckman Cholinesterase Reagent Kit | Beckman | DIH | Class I | |
| K893528 | Oticon I22p Custom Full Concha (Ite) Hrng Aid | Oticon, Inc. | ESD | Class I | |
| K893519 | Twin-Fusor/uni-Fusor Blood & Fluid Infusion Cuff | Statlabs, Inc. | KZB | Class I | |
| K893506 | Innofluor Carbamazepine Calibrator Set | Innotron of Oregon, Inc. | DLJ | Class II | |
| K893469 | Amerlite Tbg Assay, Lan.0005/1005 240/144 Test Kit | Amersham Corp. | CEE | Class II | |
| K893334 | Prepowdered Vinyl Exam Gloves | Dynarex Corp. | LYZ | Class I | |
| K893236 | Dubble Butterfly Pat Exam Gloves/mfg: Quingdao Fac | China National Chemical Construction Corp.-Qingdao | LYY | Class I | |
| K892801 | Clinistat Total Bilirubin Reagent Test | Kulzer GmbH | CIG | Class II | |
| K892726 | Ifa Sensibac Penicillin | Investigacion Farmaceutica S.A. de C.V. | JTN | Class II | |
| K892720 | Ifa Sensibac Gentamycin | Investigacion Farmaceutica S.A. de C.V. | JTN | Class II | |
| K892660 | Hibernation Kit | Devon Industries, Inc. | CAZ | Class II | |
| K892434 | Kendall Curity Oxygen Mask | The Kendal Co. | BYG | Class I | |
| K892206 | Mardx Llyme Disease Eia (Igg & Igm) Test System | Mardx Diagnostics, Inc. | LSR | Class II | |
| K891999 | Chloride Standards Item #Sr1041 | Em Diagnostic Systems, Inc. | JIT | Class II | |
| K891815 | Patient Exam Gloves (Mfg. M.r. Rubber Industries) | Mulpha Intl. Trading Corp. Bhd. | LYY | Class I | |
| K891581 | Cobas-Fp Reagent for Valproic Acid & Calibrators | Roche Diagnostic Systems, Inc. | LEG | Class II | |
| K891487 | Soft Lens Folding Block | Western Medical Products, Inc. | HNR | Class I | |
| K891471 | Sil-Med Waste Fluid Dump Bag | Sil-Med Corp. | KDG | Class I | |
| K891241 | Abbott Spectrum Amylase Reagent | Abbott Medical | JFJ | Class II | |
| K890594 | Patient Examination Glove | Tradexim Sdn Bhd | LYY | Class I | |
| K890295 | Target(tm) Ck-Mb | V-Tech, Inc. | JHY | Class II | |
| K885300 | Captia(r) Rubella-M | Mercia Diagnostics, Ltd. | LFX | Class II | |
| K885114 | Salmonella Ifa* | Investigacion Farmaceutica S.A. de C.V. | GHC | Class I | |
| K885113 | Ifa* Positive and Negative Antigens Control | Investigacion Farmaceutica S.A. de C.V. | GSN | Class II | |
| K885112 | Brucella Ifa* | Investigacion Farmaceutica S.A. de C.V. | GSO | Class II | |
| K885110 | Proteus Ox-19 Ifa* | Investigacion Farmaceutica S.A. de C.V. | GSZ | Class I | |
| K884605 | Coulter Clone Mo2 | Coulter Immunology | GKZ | Class II | |
| K883924 | Captia(r) Rubella-G | Mercia Diagnostics, Ltd. | LFX | Class II | |
| K883486 | Gonostat | Technology Management & Marketing, Inc. | LSL | Class II | |
| K882674 | Immu-Mark(tm) Chlamydia Igg/iga Kit | Icn Immunobiologicals | LKH | Class I | |
| K894599 | Shirt, Operating, Surgical | Miroz Industries Co. | FYA | Class II | |
| K894436 | Mascot o.r. Towel | Mascot, Inc. | KKX | Class II | |
| K894433 | Bates Blanket | Joe B. Bates, MD, FAAP | KKX | Class II | |
| K894404 | Emit D.a.u. Monoclonal Amphetamine/methamphetamine | Syva Co. | DKZ | Class II | |
| K894363 | Uropump* Fluid Management System | Orthoconcept, Inc. | FDC | Class II |