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 |
|---|---|---|---|---|---|
| K954203 | Massager Theraputic, Electric | Cisco Sales Corp. | IRO | Class I | |
| K954179 | Hdl Precipitating Reagent | Schiapparelli Biosystems, Inc. | LBR | Class I | |
| K953199 | Metro 55G Toric & Spherical | Metrosoft, Inc. | LPL | Class II | |
| K953102 | Bloodborne Pathogen Kit | Certified Safety Mfg Inc | FXX | Class II | |
| K953021 | Acs Phenobarbital | Ciba Corning Diagnostics Corp. | DIS | Class II | |
| K952551 | Janus I | 3D Ultrasound, Inc. | IYO | Class II | |
| K952155 | Scinitrex Blue Powdered Nitrile Examination Gloves | Wembley Rubber Products (M) Sdn Bhd | LZA | Class I | |
| K952090 | Humac System | Computer Sports Medicine, Inc. | IKK | Class II | |
| K951898 | Versa-Vu | CooperSurgical, Inc. | HIB | Class II | |
| K951682 | Octostim | Freiler | IPF | Class II | |
| K951494 | Amylase Test Item 97381/94 (R1, 97382/94 (R2-Sr) | EMD Millipore Corporation | CIJ | Class II | |
| K951028 | Hamex Two | Northern Orthopaedic Products, Inc. | BXB | Class I | |
| K946249 | Bard(r) Jejunal Feeding/gastric Decompression Tubes | C.R. Bard Inc | KNT | Class II | |
| K944612 | Acustar I Advanced Surgical Navigation System | Cerenovus, Inc. | LLZ | Class II | |
| K955479 | Koh Micro-Suturing Instruments | Karl Storz Endoscopy-America, Inc. | OCW | Class II | |
| K955346 | Vfs - 300 Bipolar Electrosurgery System | Valley Forge Scientific Corp. | GEI | Class II | |
| K955289 | Race Car Tympanometer | American Electromedics Corp. | ETY | Class II | |
| K955273 | Cannuloc Threaded Cannula | Linvatec Corporation | HRX | Class II | |
| K954754 | Wire Reinforced Silicone Endotracheal Tube | Unomedical Sdn Bhd | BTR | Class II | |
| K954753 | Pediatric Silicone Endotracheal Tube | Unomedical Sdn Bhd | BTR | Class II | |
| K954751 | Silicone Endotracheal Tube | Unomedical Sdn Bhd | BTR | Class II | |
| K954750 | Pediatric Wire Reinforced Silicone Endotracheal Tube | Unomedical Sdn Bhd | BTR | Class II | |
| K954579 | Telex 349 Multi Cros W/adapive Compression | Telex Communications, Inc. | ESD | Class I | |
| K954543 | Go Universalk-Wire Fluted Drill | Genesis Orthopedics, Inc. | HTY | Class II | |
| K954470 | Surgimotor | Novanta Medical GmbH | GEY | Class I | |
| K954376 | Mustang | Temco, Inc. | IOR | Class I | |
| K954330 | Super Screw 3.5 Mm | Osteomed | HWC | Class II | |
| K954239 | u.s. IOL Phaco Handpiece | U.S. Iol, Inc. | HQC | Class II | |
| K954238 | Surgin Genisis Handpiece | Surgin Surgical Instrumentation, Inc. | HQC | Class II | |
| K954237 | Circuit Tree Phaco Handpiece | Circuit Tree | HQC | Class II | |
| K954222 | Video Enhancement Unit | Perkins Mfg. Co. | LLZ | Class II | |
| K954216 | Olympic Warm-Bassinet | Olympic Medical Corp. | FOH | Class I | |
| K953696 | Coagulating Cannula Device | Dorsal Orthopedic Corp. | GEI | Class II | |
| K953516 | Medcomp Mc 5 Gradient Sequential Pump | Yoav Gershoni | IRP | Class II | |
| K953364 | Speculite | Trylon Corp. | HET | Class II | |
| K953042 | E-Z Breathers | E-Z Kare Good Health Systems, Inc. | LWF | Class I | |
| K952938 | Aquaflo Btp Hydrogel Wound Dressing | Sherwood Medical Co. | MGQ | Unclassified | |
| K952237 | Innovasice 2.8Mm & 3.5Mm Roc Suture Bone Fastener | Innovasive Devices, Inc. | MBI | Class II | |
| K951926 | Alreco 40400 | Allan Rehnstrom AB | BTI | Class II | |
| K934622 | Lcx Chlamydia Trachomatis Assay | Abbott Medical | MKZ | Class I | |
| K954582 | Bard Expanded PTFE Vascular Graft(modification) | C.R. Bard Inc | DSY | Class II | |
| K953987 | Acs Tourgide Guiding Catheter | Advanced Cardiovascular Systems, Inc. | DQY | Class II | |
| K952669 | Chrom Z-Plasminogen, Cat. No. 5244 | Helena Laboratories, Corp. | GGP | Class II | |
| K955290 | Kuo & Yang Sunglasses | Kuo & Yang Industrial Co., Ltd. | HQY | Class I | |
| K955141 | Osom Hcg Combo Test | Wyntek Diagnostics, Inc. | JJX | Class I | |
| K955019 | Urotract I | Dornier Medtech America, Inc. | KQS | Class I | |
| K954959 | Cap-Aid | Nebl, Inc. | FHA | Class I | |
| K954936 | Beltone Ultima 80 Otosonic Power Pas | Beltone Electronics Corp. | ESD | Class I | |
| K954912 | Trebay Irrigated Cutter Blade (Modification) | Trebay Medical Corp. | EQJ | Class I | |
| K954699 | Bray Rongeur | Johnson & Johnson Professionals, Inc. | HAE | Class II |