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 |
|---|---|---|---|---|---|
| K921154 | O.r./surgeons Gown, Item No. 4962 | The Sewing Source, Inc. | FYA | Class II | |
| K921153 | O.r./surgeons Gown, Item No. 4960 | The Sewing Source, Inc. | FYA | Class II | |
| K921152 | O.r./surgeons Gown, Item No. 4952 | The Sewing Source, Inc. | FYA | Class II | |
| K921151 | O.r./surgeons Gown, Item No. 4951 | The Sewing Source, Inc. | FYA | Class II | |
| K915052 | Latex Examination Gloves, Modification-Nonpowdered | Supertex Glove Intl. Corp. | LYY | Class I | |
| K932643 | Lyphochek(r) Urine Toxicology Screen-Low Control | Bio-Rad | DIF | Class I | |
| K932280 | Rae(r) II Tracheal Tube | Mallinckrodt Medical | BTR | Class II | |
| K932279 | Opus(r) Total B-Hcg Test System | Pb Diagnostic Systems, Inc. | JHI | Class II | |
| K932175 | Phonak Lexa 231X Ite Series Hearing Sinstrument | Phonak, Inc. | ESD | Class I | |
| K932130 | Freedom Plus (Code Name Misc-Lib-013) | J.F. Jelenko & Co., Inc. | EJT | Class II | |
| K932039 | G-Cera Orbit Colour Communication Set | GC America Inc. | EIH | Class II | |
| K932013 | Charisma -- Modified | Kulzer GmbH | EBF | Class II | |
| K931933 | Chad Labs Adhesive Bandage Remover | Chad Labs Corp. | KOX | Class I | |
| K931880 | Profill Lc Composite | Jedental Co., Inc. | EBF | Class II | |
| K931838 | Denthesive II | Kulzer GmbH | KLE | Class II | |
| K931812 | New Dentine Adhesive | Dentsply Intl. | KLE | Class II | |
| K931663 | Nitanium Pro Form Archwires,round,square,rectangul | Ortho Organizers Inc | EJF | Class I | |
| K931599 | Hydrasorb Sterile Dressing | Calgon Vestal Div. | MGP | Unclassified | |
| K931475 | Argelite 55 | Argen Precious Metals, Inc. | EJT | Class II | |
| K931257 | Acetasite | Gds Diagnostics | LDP | Class II | |
| K931229 | Variglass Vlc Glass Ionomer | Dentsply Intl. | EMA | Class II | |
| K931204 | As3000 Operative Dental Unit (Delivery System) | Den-Tal-Ez Mfg Co., Inc. | EIA | Class I | |
| K931064 | The Blendtone Epilator | Instantron | KCW | Class I | |
| K931063 | The Elite Epilator | Instantron | KCW | Class I | |
| K931062 | The Vp500 Epilator | Instantron | KCW | Class I | |
| K931056 | Davis+geck Valtrac Biofrag Anastomosis Ring | American Cyanamid Co. | GDW | Class II | |
| K930882 | Urological Catheter & Accessories | Applied Medical Resources Corp | FAD | Class II | |
| K930560 | Mpm Hydrogel Saturated Dressing | MPM Medical | MGQ | Unclassified | |
| K930452 | Solo Ties | Zulaf, Inc. | EJF | Class I | |
| K930203 | Model 322 Clinical Audiometer | Virtual Corp. | EWD | Unclassified | |
| K926389 | Sween Wound Care-Collagen Wound Dressing | Sween Corp. | MGQ | Unclassified | |
| K926382 | Therasnore | Dr. Thomas E. Meade | LRK | Class II | |
| K926206 | Posicam-Hz & Posicam-Hzl | Positron | KPS | Class II | |
| K926110 | Asi Ligasure(tm) Suture Ligation Instrument | Advanced Surgical Intervention, Inc. | GCJ | Class II | |
| K925859 | Readar/susceptibility, Gram Negative Panels | Alamar Biosciences, Inc. | LRG | Class II | |
| K925602 | Davis+geck Absorbable Ligating Device | Davis & Geck, Inc. | GCJ | Class II | |
| K925359 | Resilience Orthodontic Bracket Adhes W/bond Resins | Confi-Dental Products Co. | DYH | Class II | |
| K925354 | Combison(r) 311 | Kretztechnik AG | IYO | Class II | |
| K925207 | Glass Ionomer Cement | Milton Hodosh, M.D. | EMA | Class II | |
| K925091 | Ivac Syring Pump Model 770 | Y | FRN | Class II | |
| K924982 | Consepsis(tm) | Ultradent Products Inc. | LBH | Class II | |
| K924975 | The Orthotrainer | Myofunctional Research Corp. Pty. Ltd. | KMY | Class I | |
| K924794 | Transparent Adhesive Dressing | Medical Concepts Development, Inc. | KGX | Class I | |
| K924242 | Disposable Perforator | Cerenovus, Inc. | HBF | Class II | |
| K924208 | Bio-Probe(r) Blood Flow Monitoring Syst(tx-50/50P) | Medtronic Bio-Medicus, Inc. | DPT | Class II | |
| K924132 | E.z. Temep, Temporary Filling Material | Cosmedent, Inc. | EMA | Class II | |
| K921893 | Colgate Odontoson Ultrasonic Scaler | Perio-Giene | ELC | Class II | |
| K921452 | Acoustic Rhinometer | Hood Laboratories | BXQ | Class II | |
| K920478 | Tuttnauer Lsi (Automatic) | Tuttnauer Ltd. | FLE | Class II | |
| K926143 | Angiolapcath Cholangiography Kit | BD Becton Dickinson Vacutainer Systems Preanalytic | GBZ | Class I |