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 |
|---|---|---|---|---|---|
| K914015 | Clement-Pilling Cholangiography Cath Guide/clamp | Pilling Co. | GBZ | Class I | |
| K912575 | External Gastrostomy Tube Retainer | Sandoz Nutrition | FPD | Class II | |
| K911844 | Hysteroflator 1500 | F.M. Wiest USA, Inc. | HIG | Class II | |
| K910448 | Snap-Lock Micro Port, Modification | Infusaid Corp. | LJT | Class II | |
| K914616 | Kleer(tm) Orthodontic Bracket | Ormco Corp. | EJF | Class I | |
| K913794 | Simpex Inc. Surgical Dressing | Simpex, Inc. | GDY | Class I | |
| K913763 | Interpret(tm) Catheter Linear Translator | Intertherapy, Inc. | LYK | Class II | |
| K913758 | Ktp/532 and Ktp/yag | Laserscope | GEX | Class II | |
| K913015 | Heart Nebulizer Flowmeter Adaptor | B & B Medical Technologies, Inc. | CAF | Class II | |
| K911118 | Dtf-1000Ll,dtf-1000 | Cp Medical | EIB | Class I | |
| K914872 | Marlow Suction/irrigation Probes | Marlo Surgical Technology | GSJ | Class II | |
| K914806 | Abuscreen(r) Ontrak(r) Positive Reference Control | Roche Diagnostic Systems, Inc. | DIF | Class I | |
| K914731 | Trace Gamma Gt-Ss Reagent | Trace Scientific, Ltd. | JQB | Class I | |
| K914525 | Flurospot H Version 2 | Siemens Medical Solutions USA, Inc. | JAA | Class II | |
| K914510 | Calcium/lithium Test Beckman Synchron El-Ise Analy | Beckman Instruments, Inc. | JFN | Class II | |
| K914358 | Encapsulated Guidewire with Flexible Tip | Hobbs Medical, Inc. | EYB | Class II | |
| K914226 | Aca(r) Beta-2-Microglobulin (B2m) Test Pack | E.I. Dupont de Nemours & Co., Inc. | JZB | Class I | |
| K914091 | Power Recliner Wheelchair | Everest & Jennings, Inc. | ITI | Class II | |
| K914085 | Hms-5000 | Vitalog Monitoring,Inc. | BZG | Class II | |
| K913928 | Surgitek(r) 4.5Fr Lubri-Flex(tm) Ureteral Stent | Surgitek Medical Engineering Corp. | FAD | Class II | |
| K913827 | Model 7700A/77010a/77025a/77030a/77035a Ultra Imag | Hewlett-Packard Co. | DPW | Class II | |
| K913805 | Miniature Models 4562/4563/4572/4573 Pacemaker | Pace Medical | DTE | Class II | |
| K913772 | Pressure Guard | Beacon Laboratories, Inc. | HIF | Class II | |
| K913755 | Statview | Image Systems, Inc. | LLZ | Class II | |
| K913519 | Sumo Glass Ionomer Cement | Ortho Source | EMA | Class II | |
| K913427 | Sickle Hemoglobin (Hba/s) Control Set | Creative Laboratory Products, Inc. | JCM | Class II | |
| K912937 | Sr1 Free T4 Enzyme Immunoassay | Serono-Baker Diagnostics, Inc. | CEC | Class II | |
| K912600 | Interpret(tm) Intravascular Imaging Catheter | Intertherapy, Inc. | ITX | Class II | |
| K912516 | Classic-II 4-Way Horizontal Table Cat.# T-9111 | Continental X-Ray Corp. | IZZ | Class II | |
| K912281 | Es1600 Paramedic Telephone | Epic Systems Corporation | DXH | Class II | |
| K911795 | Kinesthetic Ability Trainer (K.a.t., Model 1000) | Breg, Inc. | LXV | Unclassified | |
| K911680 | Quanta Lite(tm) Aca | Inova Diagnostics, Inc. | MID | Class II | |
| K911503 | Exmoor Silicone Rubber Sheet | Exmoor Plastics Limited | KHJ | Class II | |
| K911400 | Walkaway Tm 40 | Baxter Healthcare Corporation | LRG | Class II | |
| K911114 | Interson Endocavity Probe/aloka Ultrasound System | Interson Corp. | ITX | Class II | |
| K911111 | Micromills, Patriots, Alpha Gold Diamonds | Vermont Diamond Instruments | EHJ | Class I | |
| K901704 | Relief Band (t.e.n.s. Device) | Maven Labs, Inc. | GZJ | Class II | |
| K913735 | Songer(tm) Cable System | Danek Medical, Inc. | JDQ | Class II | |
| K913692 | Venous Reservoir Bag Model No. Bmr-250(Tm) | Bentley Laboratories, Inc. | DTN | Class II | |
| K913684 | Davol Post-Op Autotransfusion System | Davol, Inc. | CAC | Class II | |
| K913682 | Merit Custom Kit | Merit Medical Systems, Inc. | DQO | Class II | |
| K913430 | Iris Oculight(r) Slx | Iriderm Div. | GEX | Class II | |
| K912015 | Tbd, Empi Buffered Iontophoresis Electroded Mdl. 3 | Empi | EGJ | Class II | |
| K911939 | Sas Rubber Products Co./latex Examination Gloves | Overseas Import & Export Dist. | LYY | Class I | |
| K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | JDR | Class II | |
| K904377 | Electroconductive Media | Henley Intl. | GYB | Class II | |
| K912880 | Vitalmax 510/520 | Pace Tech, Inc. | DQA | Class II | |
| K914851 | Cla-1400 System | Gaymar Industries, Inc. | IOQ | Class II | |
| K914697 | Mdt/castle Purus Dental Unit | Mdt Corp., Inc. | EIA | Class I | |
| K914696 | Medix Biotech Total Hcg Enzy Immun Test Kt Dif4011 | Medix Biotech, Inc. | JHI | Class II |