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 |
|---|---|---|---|---|---|
| K955798 | Igg Immunoturbidimetric & Calibrator | Randox Laboratories, Limited | DEW | Class II | |
| K955797 | Igm Immunotrubidimetric & Calibrator | Randox Laboratories, Limited | DFT | Class II | |
| K955794 | Iga Immunoturbidimetric & Calibrator | Randox Laboratories, Limited | CZP | Class II | |
| K955352 | Suction Cautery Probe | Mectra Labs, Inc. | GEI | Class II | |
| K955175 | Acs Anchor Exchange Device | Advanced Cardiovascular Systems, Inc. | DQX | Class II | |
| K955117 | Implex Ceramic Head | Implex Corp. | LZO | Class II | |
| K953971 | Triglycerides Liquid Stable Incorporating Dynamic Stabilisation Technology | Trace America, Inc. | CDT | Class I | |
| K950157 | Siemens Q64xxx | Siemens Medical Solutions USA, Inc. | IYO | Class II | |
| K944676 | Mri's All Silicone Foley Catheter | Mri Manufacturing and Research, Inc. | EZL | Class II | |
| K960914 | 3I Osseous Fixation System(s) | ZimVie US Corp LLC | JEY | Class II | |
| K960847 | Dermaseal | Bellingham Medical, Inc. | MGP | Unclassified | |
| K960523 | Nhmc Dressing Tray | National Healthcare Mfg. Corp. | EFQ | Unclassified | |
| K960509 | 18 Gauge Tru-Cut Biopsy Needle | Baxter Healthcare Corporation | KNW | Class II | |
| K960420 | Mueller Hinton Agar with 5% Sheep Blood | Becton Dickinson Microbiology Systems | JTZ | Class II | |
| K960413 | Coherent Slimline Single Lumen Aspiration Needle Kit | Lumenis Ltd | GEX | Class II | |
| K960410 | Perfect Ear Pe/pe-Agc/pe-B/pe-Pwr | Perfect Ear | ESD | Class I | |
| K960280 | Ivac Needle Free Valve Administration Sets | Y | FPA | Class II | |
| K960273 | Harmonie Sensa | Stellate Systems | OMB | Class II | |
| K960269 | Titanium Universal Clamp | Synthes (USA) Products LLC | LXT | Class II | |
| K960245 | Vip Victor Interactive Probe | Pro-Dentec | EIX | Class I | |
| K960209 | CPR Heart Pack | Custom Pack Reliability | GAW | Class II | |
| K960089 | Prochek G Glutaraldehyde Concentration Level Indicator | Cottrell, Ltd. | JOJ | Class II | |
| K960084 | Hichem Glucose/hk Reagent Kit | Hi Chem, Inc. | CFR | Class II | |
| K955568 | Innofluor Quinidine Assay System | Oxis Intl., Inc. | LBZ | Class II | |
| K955398 | Formulation Preparation Device | B.Braun Medical, Inc. | LHI | Class II | |
| K955237 | Tigerscan/tigerview | Tau Corp. | LMB | Class I | |
| K954999 | Lily Multicannula Guide | Lily Imaging Solutions Co. | KNW | Class II | |
| K954598 | Osteonics Offset Hip Stems | Osteonics Corp. | JDI | Class II | |
| K953355 | Gip/meid-Globe Hot Biopsy Forceps | Medi-Globe GmbH | KGE | Class II | |
| K952807 | Temperature Probe-Tp650 | Contour Medical Technology, Inc. | FMT | Class II | |
| K952805 | Temperature Probe-Tp550 | Contour Medical Technology, Inc. | FMT | Class II | |
| K952804 | Temperature Probe-Tp450 | Contour Medical Technology, Inc. | FMT | Class II | |
| K952803 | Temperature Probe-Tp350 | Contour Medical Technology, Inc. | FMT | Class II | |
| K952801 | Temperature Probe-Tp250 | Contour Medical Technology, Inc. | FMT | Class II | |
| K952800 | Temperature Probe-Tp150 | Contour Medical Technology, Inc. | FMT | Class II | |
| K951620 | Midmark Midline Catheter | Menlo Care, Inc. | FOZ | Class II | |
| K951130 | Cardiosoft/cardiosys | Marquette Electronics, Inc. | LOS | ||
| K935732 | Cardio Perfect St 2001 | Cardio Control BV | DSI | Class II | |
| K960998 | Xre Collimator | Xre Corp. | IZW | Class II | |
| K960997 | Starswab Culture Collection and Transport System | Starplex Scientific Corp. | LIO | Class I | |
| K960935 | Audio 'D' 2N Series Hearing Aids(full Shell Ite,half Shell Ite, Mini Canal, Canal) | Hearing Solutions, Inc. | ESD | Class I | |
| K960862 | Lipid Control | Medical Analysis Systems, Inc. | JJY | Class I | |
| K960853 | Ace System | Xomed, Inc. | EQJ | Class I | |
| K960742 | Tympanostomy Ventilation Tube | Advanced Microbotics Corp. | ETD | Class II | |
| K960635 | Pulmo CT with Reference Database for the Somatom Plus and Plus 4 Computed Tomography Systems | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K960557 | Calibration Verification Assessment (Cva) | Streck Laboratories, Inc. | JPK | Class II | |
| K960500 | The Virtual M-332 | Virtual Corp. | EWD | Unclassified | |
| K960378 | Ena-C-T Assayed Total Cholesterol Controls | Actimed Laboratories, Inc. | JJX | Class I | |
| K955677 | Synchron Systems Cannabinoid 20 Ng Reagent | Beckman Instruments, Inc. | LDJ | Class II | |
| K955115 | Venom Tiem Reagent | Medical Diagnostic Technologies, Inc. | JCO | Class II |