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 |
|---|---|---|---|---|---|
| K964715 | Paramax Salicylate Reagent | Dade Intl., Inc. | DKJ | Class II | |
| K962930 | Spacelabs Medical ECG Analysis System | GE Healthcare | DQK | Class II | |
| K954204 | Drager Incubator 8000 Ic | Drager, Inc. | FMZ | Class II | |
| K953982 | Simplex TENS | Armstrong Industries, Inc. | GZJ | Class II | |
| K941514 | Ventana Anti-S100 Primary Antibody | Ventana Medical Systems Inc | DEH | Class II | |
| K970931 | Copalis Torc Total Antibody Assay | Sienna Biotech, Inc. | LQN | Class II | |
| K970832 | Pyr Swab | Remel Inc | JTO | Class I | |
| K970697 | Osteonics Normalized Ad Acetabular Component System | Osteonics Corp. | JDI | Class II | |
| K970574 | Acupuncture Needles | C.A.I. Industries Corp. | MQX | Class II | |
| K970519 | Unitron Model Sound F/x Programmable Ite (Sf/x Programmable) | Unitron Industries, Inc. | ESD | Class I | |
| K970392 | Cordis Avanti+catheter Sheath Introducer System | Cordis US Corp. | DRE | Class II | |
| K970299 | Jupiter Pta Catheters (Various) | Cordis US Corp. | LIT | Class II | |
| K970291 | Accessories to the Stereotactic Body Fram | Elekta Instrument AB | IYE | Class II | |
| K970288 | Clinical Diagnostic Software | Nuccardiac Software, Inc. | KPS | Class II | |
| K965183 | Vantage Peripheral Dilatation Catheter | Boston Scientific Corporation | LIT | Class II | |
| K963996 | (Fsi) Laparoscopic Probe for All Fsi Ule Ff101 Fibers. Model Fsi Ff101-Lp-Xxx, Where Xxx = Fiber Diameters 100, 200, 400 | Full Spectrum, Inc. | GEX | Class II | |
| K963991 | Fsi Laparoscopic Probe for All Fsi Ule-Overclad Ff201 Fibers | Full Spectrum, Inc. | GEX | Class II | |
| K963989 | P.d. Access (Percutaneous Doppler) Vascular Access Device | Cardiovascular Dynamics, Inc. | ITX | Class II | |
| K963886 | Evs | Applied Medical Resources Corp | DYB | Class II | |
| K962936 | Immulite Toxoplasma Quantitative Igg | Siemens Healthcare Diagnostics Inc. | LGD | Class II | |
| K962882 | Sonoline Versa Pro Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYO | Class II | |
| K960764 | Safe-Cath | Scientific Device Manufacturer, LLC | FOZ | Class II | |
| K971092 | Qa-Es | Smith | GEI | Class II | |
| K971071 | Liquid Ligand 1,2,3 | Chiron Diagnostics Corp. | JJY | Class I | |
| K971014 | Lifescan Surestep Pro Glucose Control/linearity Solutions | Lifescan, Inc. | JJX | Class I | |
| K970969 | Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement Set | The Kendal Co. | KOB | Class II | |
| K970949 | Smith & Nephew Mis Instruments | Smith & Nephew Endoscopy, Inc. | GCJ | Class II | |
| K970930 | Bilateral Infant Cleft Palate Orthodontic Appliance | Cleft Palate Appliances, Inc. | DYJ | Class I | |
| K970631 | Punctual Occluder | Odyssey Medical, Inc. | LZU | Unclassified | |
| K970341 | Medtronic Ps Medical Rivas Vascular Catheter Repair Kit | Medtronic PS Medical | LIS | ||
| K970292 | In-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw | Influence, Inc. | MBI | Class II | |
| K970266 | Kendall Hydrophilic Powder Wound Dressing | Kendall Healthcare Products Co. Div.Of Tyco Health | KGN | Unclassified | |
| K970033 | Monarch IOL Delivery System | Alcon Laboratories | KYB | Class I | |
| K965139 | Surgical Microscope Navigator (Smn) System/surgical Tool Navigator (Stn) System | Carl Zeiss, Inc. | HAW | Class II | |
| K964956 | E-Z Spacer Mask (Small) | Airpharma, LLC | CCQ | Class I | |
| K964756 | Prostatic Acid Phosphatase Reagent Test/prostatic Acid Phosphatase Reagent Kit | Wano-Tech Corp. | JFH | Class II | |
| K964393 | Chase Retrograde Cardioplegia Cannula | Chase Medical, Inc. | DWF | Class II | |
| K964377 | Thermal Regulation System Blanket | Gibeck, Inc. | DWJ | Class II | |
| K964288 | Call-Rad Pc Teleradiology | Pc Teleradiology | LMA | Class II | |
| K964152 | Unicap Total Ige Assay/pharmacia Total Ige Controls Lmh | Pharmacia, Inc. | DGC | Class II | |
| K963223 | Ez-Circ | Phyllis Adams, Rn, Npc, Msn | HFW | Class II | |
| K962087 | Servotronic Ec100 System | Medicon Co., Ltd. | HWE | Class I | |
| K970966 | Comfort Cath Choice Male External Catheter | Sierra Laboratories, Inc. | EXJ | Class I | |
| K970764 | Comeg Endoscopy Resectoscope Accessories | Comeg Endoscopy | OCX | Class II | |
| K970524 | Safe-Connect i.v. Extension Set | Faulding Medical Device Co. | FPA | Class II | |
| K970394 | Osteonics Normalized Ad-Ha Acetabular Component System | Osteonics Corp. | MEH | Class II | |
| K970350 | Equi-Pise 1000 Mrs | Advanced Air Support Consultancy, Inc. | FNM | Class II | |
| K970307 | Minnova Pelvic Floor Stimulation System | Empi | KPI | Class II | |
| K970144 | Vinyl Exam Glove Powered | Hiyi Export Co. | LYZ | Class I | |
| K965095 | Nitra-Touch Powder-Free Nitrile Medical Examination Glove | Ansell Edmont Industrial, Inc. | LZA | Class I |