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 |
|---|---|---|---|---|---|
| K000201 | Hardydisk, Streptomycin 10Mcg | Hardy Diagnostics | JTN | Class II | |
| K000182 | Hardydisk Tobramycin, 10Mcg | Hardy Diagnostics | JTN | Class II | |
| K000173 | Cement It! Universal C&b | Jeneric/Pentron, Inc. | EMA | Class II | |
| K000152 | Kippmed i.v. Manifold | The Kipp Group | FPA | Class II | |
| K000130 | Hardydisk, Nalidixic Acid, 30Mcg | Hardy Diagnostics | JTN | Class II | |
| K000071 | Synthetic Powder Free (White) Vinyl Patient Examination Gloves | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | LYZ | Class I | |
| DEN000004 | Quickair Choke Reliever, Model 59-001A | Maet Industries, Inc. | MZT | Class II | |
| K994327 | Embryon Transfer Catheters/sets | Rocket Medical | MQF | Class II | |
| K994217 | Blackstone Spinal Fixation System | Blackstone Medical, Inc. | MNH | Class II | |
| K993401 | Dryspot E.coli 0157 Kit | Oxoid, Ltd. | GNA | Class I | |
| K993036 | Zoll M Series Etco2 Option | ZOLL Medical Corporation | MKJ | Class III | |
| K992715 | Neuro Urodynamic Suite, Model 9032E0101 | Medtronic Functional Diagnostics A/S | FEN | Class II | |
| K992147 | Triple-Fix Spinal Fixation System | Advanced Spine Technology, Inc. | MNI | Class II | |
| K991335 | Medi-Cult Freezing & Thawing Packs | Medicult A/S | MQL | Class II | |
| K991333 | Medi-Cult Sperm Freeze Medium | Medicult A/S | MQL | Class II | |
| K000409 | Modification to T-Rex Biopsy Forceps | Boston Scientific Corporation | DWZ | Class II | |
| K000318 | Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact Blood Glucose Monitoring System | Bionostics, Inc. | JJX | Class I | |
| K000183 | Hardydisk, Piperacillin, 100Mcg | Hardy Diagnostics | JTN | Class II | |
| K000007 | Immulite Carbamazepine, Immulite 2000 Carbamazepine, Catalog # Lkcb1, Lkcb5 & L2kcb2, L2kcb6 | Siemens Healthcare Diagnostics Inc. | KLT | Class II | |
| K000006 | Immulite Phenytoin, Immulite 2000 Phenytoin, Catalog # Lkpn1, Lkpn5 & L2kpn2, L2kpn6 | Siemens Healthcare Diagnostics Inc. | DIP | Class II | |
| K994229 | Veripath Peripheral Guiding Catheter | Advanced Cardiovascular Systems, Inc. | DQY | Class II | |
| K994202 | Acufex Spiked Washer System, Acufex Suture Washer System, Acufex Cancellous Screw and Spiked Washer System | Smith & Nephew, Inc. | HWC | Class II | |
| K994153 | Cormet 2000 Hemi Hip Metallic Resurfacing Prosthesis | Corin USA | KXA | Class II | |
| K994044 | Cleen-Able | Vital Signs, Inc. | DXQ | Class II | |
| K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | JDR | Class II | |
| K993515 | Medefil's Normal Saline Flush Syringe, in Various Fill Sizes - 1 Ml Fill in 3 Ml Syringe Ll; 1 Ml Fill in 6 Ml Syringe L | Medefil, Inc. | FOZ | Class II | |
| K993017 | Profi Disposable Syringe, Profi Disposable Needle, Dm Ject Insulin Syringe | ShinChang Medical Co., Ltd. | FMF | Class II | |
| K992220 | Radial Head Prosthesis | Smith & Nephew, Inc. | KWI | Class II | |
| K991351 | Ovoil-150, Model 5002 | Vitrolife Sweden AB | MQL | Class II | |
| K991330 | Medi-Cult Liquid Paraffin | Medicult A/S | MQL | Class II | |
| K991329 | Medi-Cult Pvp Medium, Medi-Cult Pvp Clinical Grade | Medicult A/S | MQL | Class II | |
| K980951 | Oneflow | Sti Medical | BZH | Class II | |
| K000430 | Affinity Nt Hollow Fiber Oxygenator with Plasma Resistant Fiber with Carmeda Bioactive Surface, Model Cb511 | Medtronic, Inc. | DTZ | Class II | |
| K000335 | Mallory-Head Modular Calcar Total Hip System | Zimmer GmbH | LPH | Class II | |
| K000319 | Ebi Xfix Dfs System | Ebi, LLC | KTT | Class II | |
| K000232 | Rotaglide + Modular Knee System with Fixed Meniscus | Corin USA | JWH | Class II | |
| K994369 | 7250 (Megas) | Esaote North America, Inc | IYN | Class II | |
| K994033 | Hortmann Echomaster Oae Analyzer | Hortmann AG | EWO | Class II | |
| K994014 | Esc Intense Pulsed Light Systems: Epilight and Multilight | Esc Medical Systems, Ltd. | GEX | Class II | |
| K993514 | Definite | Degussa - Ney Dental, Inc. | EBF | Class II | |
| K992638 | Dinamap Pro Series Monitor, Models 100, 200, 300, 400 | Critikon Company, LLC | MWI | Class II | |
| K991346 | Ph-100, Model 2104 | Vitrolife Sweden AB | MQL | Class II | |
| K000572 | E.n.s.i. Syringe | Tri-Ject Intl. Corp. | MEG | Class II | |
| K000316 | Meretek Ubt_lite Breath Test for H. Pylori | Meretek | MSQ | Class I | |
| K000220 | Ma-300 Electromyography System | Motion Lab Systems, Inc. | IKN | Class II | |
| K000056 | Bio-Lipid Human Serum Hdl and Ldl Calibrators | Biocell Laboratories, Inc. | JJX | Class I | |
| K000034 | Ois-Stand Alone Diagnostic Ultrasound System | Optimal Imaging Systems, Inc. | IYN | Class II | |
| K994421 | Snn Stereotaxic Planning Application; Snn Stereotactic Application | Surgical Navigation Specialists, Inc. | HAW | Class II | |
| K994356 | Immunocyt | Diagnocure, Inc. | NBK | Class II | |
| K994324 | Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and Visibility Tinted with UV Blocker | Vistakon, Johnson & Johnson Vision Products, Inc. | LPL | Class II |