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 |
|---|---|---|---|---|---|
| K903345 | Bard (R) Lubricious - Coated Ureteral Stent Suture | C.R. Bard Inc | FAD | Class II | |
| K911544 | Solaro 4 | Metalor Dental USA Corp. | EJT | Class II | |
| K911543 | Solaro 3 | Metalor Dental USA Corp. | EJT | Class II | |
| K911542 | Pontor 2 | Metalor Dental USA Corp. | EJT | Class II | |
| K911541 | Pontor 4 Cf | Metalor Dental USA Corp. | EJT | Class II | |
| K911540 | Proth-Auro 22 | Metalor Dental USA Corp. | EJT | Class II | |
| K911539 | Aurofluid 3 | Metalor Dental USA Corp. | EJT | Class II | |
| K911538 | Aurofluid 2 | Metalor Dental USA Corp. | EJT | Class II | |
| K911537 | V-Delta, Sf | Metalor Dental USA Corp. | EJT | Class II | |
| K911536 | V-Deltabond | Metalor Dental USA Corp. | EJT | Class II | |
| K911535 | V-Classic | Metalor Dental USA Corp. | EJT | Class II | |
| K911534 | V44 | Metalor Dental USA Corp. | EJT | Class II | |
| K911533 | V92 | Metalor Dental USA Corp. | EJT | Class II | |
| K911532 | V-Super | Metalor Dental USA Corp. | EJT | Class II | |
| K911531 | V-Supergold | Metalor Dental USA Corp. | EJT | Class II | |
| K911530 | V-Gnathos | Metalor Dental USA Corp. | EJT | Class II | |
| K911522 | Arthrobot(tm) Wrist Holder Accessory | Andronic Devices, Ltd. | JEA | Class I | |
| K911479 | Laparoscopic Insuflation Y Tubing | United States Endoscopy Group, Inc. | HIF | Class II | |
| K911478 | Laparoscopic Snare Pouch | United States Endoscopy Group, Inc. | GCJ | Class II | |
| K911393 | Rubenostika Igg Microelisa System | bioMerieux, Inc. | LFX | Class II | |
| K911316 | Insulated Hook Scissors/j & L Hook Knives/spatula | Northgate Technologies Inc. | GEI | Class II | |
| K911309 | Ust-974-5 Convex Transducer | GE Medical Systems Information Technologies, Inc. | ITX | Class II | |
| K911093 | Ciba Corning Acs T Uptake Immunoassay | Ciba Corning Diagnostics Corp. | KHQ | Class II | |
| K910860 | All-Bond 2 | Bisco, Inc. | KLE | Class II | |
| K910741 | Heparin Controls, High and Low | Sigma Diagnostics, Inc. | KFF | Class II | |
| K910719 | Silicoater Md | Kulzer GmbH | EMA | Class II | |
| K910677 | Immulite(tm) T-Uptake | Cirrus Diagnostics, Inc. | CEE | Class II | |
| K910672 | J&s Pediatric Iron Saturating Reagent | J.S. Medical Assoc. | JQE | Class I | |
| K910641 | Introducer Needles | Akcess Medical Products, Inc. | KOC | Class II | |
| K910636 | ABS Cadkit | Panbio Limited | GIS | Class II | |
| K910572 | Injection Caps | Akcess Medical Products, Inc. | FOZ | Class II | |
| K910557 | Barrier* Extra Protection Plus Face Mask | Johnson & Johnson MEDICAL GmbH | FXX | Class II | |
| K910546 | Piggy Lock Needle Housing | Abbott Medical | FPA | Class II | |
| K910516 | Disposal Pad for Sharps | Visitec Co. | MMK | Class II | |
| K910502 | Vessel Dilators | Akcess Medical Products, Inc. | FKA | Class II | |
| K910501 | Permanent Silicone Catheters | Akcess Medical Products, Inc. | LFJ | Class II | |
| K910423 | Bronchoscope Bf-N20 | Olympus Corp. | EOQ | Class II | |
| K910246 | Core Disposable Suction/irrigation Tubing | Core Dynamics, Inc. | GCJ | Class II | |
| K910209 | Laparoscopic Irrigator/aspirator | Solos Mfg. | HET | Class II | |
| K910049 | Interspec Apogee, Modification | Interspec, Inc. | DPW | Class II | |
| K905787 | Vidas Chlamydia Assay Vitek Immundiag Assay Syst | Vitek Systems, Inc. | LJC | Class I | |
| K905702 | New Triad Transheet Denture Base Material | Dentsply Intl. | EBI | Class II | |
| K905582 | Potassium Nitrate Composite Restoration Pit and | Milton Hodosh, M.D. | EBC | Class II | |
| K905495 | Hysteromat Hysteroflator Hysteroscopic Insufflator | Frigitronics, Inc. | HIG | Class II | |
| K905039 | Implant, Threaded External Hex, Tapered Shoulder | Minimatic Implant Technology | DZE | Class II | |
| K904951 | S5192r Transducer | Acuson Corp. | MAA | Class II | |
| K904707 | Bc 1208 Implant, Threaded External Hex | Minimatic Implant Technology | DZE | Class II | |
| K904392 | Multilab 2000 | Unetixs, Inc. | JAF | Class II | |
| K904090 | Orthodontic Bonding Adhesive Control | Lancer Orthodontics, Inc. | DYH | Class II | |
| K901804 | Norland Xr26 Whole Body Option | Norland Corp. | KGI | Class II |