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 |
|---|---|---|---|---|---|
| K890005 | Type 9225 Nibp | S & W Medico Teknik | DXN | Class II | |
| K885327 | Philips Digital Cardiac Imaging (Dci) System | Philips North America LLC | LMB | Class I | |
| K883601 | Epstein-Barr Virus (Ebna-1) Igm Cata. #5550 | Clinical Sciences, Inc. | LLM | Class I | |
| K883600 | Epstein-Barr Virus (Ebna-1) Igg Cata. #4550 | Clinical Sciences, Inc. | LLM | Class I | |
| K882437 | L3 (Lead Latex Lysnig Gloves) | The Branford Co. | LZC | Class I | |
| K892337 | Behind-the-Ear Hearing Aid Model 46 Pp Pc | Qualitone | ESD | Class I | |
| K892261 | Rubber Dam Clamps/forceps | Zinnanti Surgical Instruments, Inc. | EKJ | Class I | |
| K891594 | Cerumen Filter | GN Danavox, Inc. | ESD | Class I | |
| K891327 | Nickle-Titanium Orthodontic Wire | American Orthodontics | FJF | Class II | |
| K891240 | Direct Bilirubin for Continuous Flow | Catachem, Inc. | CIG | Class II | |
| K891086 | Stat Test Kit for Eb-Vca Igg Antibody | Whittaker Bioproducts, Inc. | LSE | Class I | |
| K890772 | Ultrasonic Imaging Catheter for Cardiac Appli. | Boston Scientific Corporation | IYO | Class II | |
| K890742 | Intraform Total Hip System | Orthomet, Inc. | JDI | Class II | |
| K884952 | Various Femoral Hip Prostheses W/self Lock Ceramic | Protek, Inc. | LZO | Class II | |
| K884810 | Silicone Laryngeal Stent | Hood Laboratories | FWN | Class II | |
| K892700 | E65 35 Prone Stander | Rifton Equipment for the Handicapped | INW | Class I | |
| K892699 | E613 Pair of Support Blocks | Rifton Equipment for the Handicapped | INW | Class I | |
| K892698 | E655 Adjustable Abduction Block W/hip Stabilizer | Rifton Equipment for the Handicapped | INW | Class I | |
| K892697 | E653 Oblong Abduction Block | Rifton Equipment for the Handicapped | INW | Class I | |
| K892550 | Best Colon Clamp | Zinnanti Surgical Instruments, Inc. | FFN | Class I | |
| K892542 | Rectal Specula - Chelsea-Eaton, Kelly, Mathieu | Zinnanti Surgical Instruments, Inc. | FFN | Class I | |
| K892526 | Spq Tm Test System II for Crp | Atlantic Antibodies | DCK | Class II | |
| K892421 | Modified Access R-Clone Ana/rf Screening Test | Lipogen, Inc. | LJM | Class II | |
| K892362 | Amerlite Ferritin Assay (Additional Protocol) | Amersham Corp. | DBF | Class II | |
| K892198 | Technicon Dpa-1 (Tm) Crp Method | Technicon Instruments Corp. | DCK | Class II | |
| K891929 | Moni-Trol(r) | Baxter Healthcare Corporation | JJY | Class I | |
| K891869 | Cls 962 Microplate Photometer | Cambridge Life Sciences PLC. | JJQ | Class I | |
| K891470 | Ck-Nac 2-Vial Reagent W/substrate Start | Trace Scientific, Ltd. | CGS | Class II | |
| K891135 | Phadiatop Paediatric Ria and Eia | Pharmacia, Inc. | DHB | Class II | |
| K890671 | Hi Chem Creatinine Reagent (Product #88809) | Hichem Diagnostics | CGX | Class II | |
| K890662 | Pent Caps | Jeneric/Pentron, Inc. | EJJ | Class II | |
| K890635 | Cavitron/kelman Phacoemulsifier Aspirator, Univ. | CooperVision, Inc. | HQC | Class II | |
| K892478 | Safetex & Suntex Patient Examination Gloves | P.T. Latexindo Prautama | LYY | Class I | |
| K892476 | Patient Examination Gloves (Latex) | Serata Glove Industries Sdn. Bhd. | LYY | Class I | |
| K892475 | Posi Shield (Patient Examination Gloves) | Clinical Supply | LYY | Class I | |
| K892474 | Posi Shield (Patient Examination Gloves) | West Chester Marketing, Inc. | LYY | Class I | |
| K892101 | Patient Exam Gloves (Mfg. Shun Tahi Rubber Gloves) | Ergo Intl., Ent., Inc. | LYY | Class I | |
| K892100 | Patient Exam Gloves (Mfg. Shun Jun Trading Co.) | Ergo Intl., Ent., Inc. | LYY | Class I | |
| K891961 | Non-Sterile Latex Examination Gloves | Union License Ent. Co., Ltd. | LYY | Class I | |
| K891956 | Patient Examination Glove | Equatorial Rubber Mfg. Industry Sdn Bhd | LYY | Class I | |
| K891942 | Patient Exam Gloves (Mfg. Jenq Chuam Industrial) | Lc Saratoga International, Inc. | LYY | Class I | |
| K891941 | Patient Examination Gloves (Vinyl) | Cypress Medical Products LLC | LYZ | Class I | |
| K891938 | Non-Sterile Patient Examination Gloves | Lien Chang Rubber Industrial Co., Ltd. | LYY | Class I | |
| K891936 | Patient Examination Gloves (Latex) | Ku Shing Industries Sdn. Bhd. | LYY | Class I | |
| K891491 | Seamless Latex Patient Examination Gloves | Digitcare Corp. | LYY | Class I | |
| K891109 | Panda(r) Needle Catheter Jejunostomy Tube | Concept, Inc. | KNT | Class II | |
| K890448 | Light Source, Endoscop, Xenon Arc | Mira, Inc. | FFS | Class II | |
| K885271 | Bdac Omicron Plus Surgical Gloves | BD Becton Dickinson Vacutainer Systems Preanalytic | KGO | Class I | |
| K892543 | Neurosurical Retractors - Various Types | Zinnanti Surgical Instruments, Inc. | GZT | Class II | |
| K892531 | Neurosurgical Drills: Stille, Hudson | Zinnanti Surgical Instruments, Inc. | HBG | Class II |