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 |
|---|---|---|---|---|---|
| K080330 | Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress Female Taper | Zimmer GmbH | KRO | Class II | |
| K080180 | Modification to Retinal Function Imager (Rfi) | Optical Imaging, Ltd. | HKI | Class II | |
| K080088 | Biomet Sports Medicine Anchor Devices and Ziploop Constructs | Biomet Manufacturing Corp | HWC | Class II | |
| K072427 | Sigma Series Hyperbaric Chamber | Perry Baromedical Corporation | CBF | Class II | |
| K081332 | Athlet Vertebral Body Replacement System | Signus Medizintechnik GmbH | MQP | Class II | |
| K081152 | T2 Femoral Nail | Howmedica Osteonics Corp | HSB | Class II | |
| K081133 | Kymco Foru, Model Eq40 | Kwang Yang Motor Co., Ltd. | INI | Class II | |
| K080755 | Soflens Daily Disposable Toric (Hilafilcon B) Visibility Tinted Contact Lens | Bausch & Lomb Incorporated | MVN | Class II | |
| K080673 | Interfuse Intervertebral Body Fusion Device | Vertebral Technologies, Inc. | MAX | Class II | |
| K080550 | Megachannel Endoscopic Overtube, Model Ot22 | Minos Medical | ODB | Class II | |
| K081318 | Onetouch Zoom Diabetes Management Program | Lifescan, Inc. | NBW | Class II | |
| K081037 | Watch-Pat 200I (Wp200i) | Itamar Medical | MNR | Class II | |
| K081003 | Trusynth, Absorbable (Polyglactin 910) Suture | Sutures India Pvt., Ltd. | GAM | Class II | |
| K081002 | Monoglyde, Absorbable (Poliglecaprone 25) Suture | Sutures India Pvt., Ltd. | GAM | Class II | |
| K081001 | Pd Synth, Absorbable (Poly Dioxanone) Suture | Sutures India Pvt., Ltd. | NEW | Class II | |
| K080932 | Mosaic Laser System | Lutronic Corporation | GEX | Class II | |
| K080773 | Thor Anterior Plating System | Howmedica Osteonics Corp | KWQ | Class II | |
| K080706 | Connexx Locking Tibia Nail | I.T.S. Implantat-Technologie-Systeme GmbH | JDS | Class II | |
| K080684 | Wg-Surgical Sutures with Needle | Foosin Medical Supplies Inc., Ltd. | GAP | Class II | |
| K080506 | Martin Chair, Model C4s1 | Martin Manufacturing Co., LLC | IOR | Class I | |
| K080366 | Duracheck Blood Pressure Cuff, Model Zdc4000 Series | Zefon Intl. | DXQ | Class II | |
| K080230 | Neb-U-Mask System, Models 1895, 1896 | Teleflexmedical, Inc. | CAF | Class II | |
| K080175 | Navigator Anesthesia Delivery System, Model 0998-00-3024-01 | Datascope Corp., Patient Monitoring Division | BSZ | Class II | |
| K080014 | Clever Chek Td-3250C Blood Glucose Plus Blood Pressure Monitoring System | Taidoc Technology Corporation | NBW | Class II | |
| K073501 | Roche Elecsys Toxo Igg Test System, Roche Elecsys Precicontrol Toxo Igg | Roche Diagnostics GmbH | LGD | Class II | |
| K073179 | Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585 | Maquet Critical Care AB | CBK | Class II | |
| K072939 | He4 Eia, Model: 404-10 US | Fujirebio Diagnostics, Inc. | OIU | Class II | |
| K072852 | Sl-Plus Standard and Lateral Hip Stems | Smith & Nephew, Inc. | LZO | Class II | |
| K081458 | Proven Stem Extender | Globus Medical, Inc. | JWH | Class II | |
| K081399 | Aviator Transport Incubator | International Biomedical, Ltd. | FPL | Class II | |
| K081296 | Preference Pedicle Screw System | Us Spine | MNH | Class II | |
| K081065 | Aplio Xg Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2 | Toshiba America Medical Systems, In.C | IYN | Class II | |
| K081032 | Tr-Usb Telephonic Stethoscope | Rnk Products, Inc. | DQD | Class II | |
| K080678 | Uni-Knee 2.0 | Brainlab, Inc. | HAW | Class II | |
| K080677 | Comfortronic 4894 and Comfortdrive 200Xda Handpiece | Kaltenbach & Voigt GmbH | EIA | Class I | |
| K080601 | Ergo++ Version 1.7 | 3D Line Medical Systems S.r.l. | MUJ | Class II | |
| K080384 | Human Cystatin C Kit for Use on Modular P Analyser | The Binding Site | NDY | Class II | |
| K080269 | Triage Cardioprofiler and Profiler S.o.b. Panels | Biosite Incorporated | NBC | Class II | |
| K080146 | Zirkondent | Ergometa | EIH | Class II | |
| K073712 | Soft Air, Model Sa 4000 and Mistral Air, Model Ma0100 | Adroit Medical Systems, Inc. | DWJ | Class II | |
| K073229 | Nerve Monitoring Cable | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | GXZ | Class II | |
| K072198 | X-Void, Spider | Sintea Biotech, Inc. | HRX | Class II | |
| K070844 | Nilimedix Adi | Nilimedix, Ltd. | LZG | Class II | |
| K081305 | Merci Retriever | Concentric Medical, Inc. | NRY | Class II | |
| K081285 | Finger Pulse Oximeter, Model 9560 | Nonin Medical, Inc | DQA | Class II | |
| K080478 | Gradia Forte | GC America Inc. | EBF | Class II | |
| K081426 | Nexstar Liftoff Pet Application Software Suite | Philips North America LLC | KPS | Class II | |
| K081417 | Foxcross Pta Catheter | Abbott Vascular | LIT | Class II | |
| K081311 | Powerport Implanted Port with Groshong Catheter | C.R. Bard Inc | LJT | Class II | |
| K081308 | Fujifilm Fcr View, Model Cr-Vw674 | FUJIFILM Healthcare Americas Corporation | LLZ | Class II |