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 |
|---|---|---|---|---|---|
| K911095 | Gsi 37 Auto Tymp | Lucas Grason-Stadler, Inc. | ETY | Class II | |
| K910962 | Cholesterol Calibrator Set | Casco Standards | JIT | Class II | |
| K910883 | Laparoflator Electronic 3509 | F.M. Wiest USA, Inc. | HIF | Class II | |
| K910797 | Streptex Acid Extraction Kit | Wellcome Diagnostics | GTZ | Class I | |
| K910726 | Light-Touch and Surgi Light Fibers | Lifestream Int'L, Inc. | GEX | Class II | |
| K910711 | Ampro Surgeon's Gloves | American Pro Latex, Inc. | KGO | Class I | |
| K910692 | Bio Scan-Bg(tm | Bio Scan Instrument, Inc. | CGA | Class II | |
| K910628 | All Bond Liner-F | Bisco, Inc. | KLE | Class II | |
| K910622 | Gesco per-Q-Cath Repair Kit | Gesco Intl., Inc. | LJS | Class II | |
| K910354 | Du Pont Identification Camera | Dupont Medical Products | JAC | Class I | |
| K910309 | Paramax(r) Electrolyte Calibrator 1&2/Modification | Baxter Healthcare Corporation | JIX | Class II | |
| K910288 | Nonstaining Alastiks | Unitek Corp. | EJF | Class I | |
| K910282 | Medi-Trace(r) Disposable Tocotonometer | Graphic Controls Corp. | HFM | Class II | |
| K910224 | Thermaprep | Tulsa Dental Products LLC | EKM | Class I | |
| K910216 | Steadfast Denture Adhesive Powder | Stiefel Research Institute, Inc. | KOM | Class I | |
| K910153 | Ust-974-5 Convex Transducer | GE Medical Systems Information Technologies, Inc. | KNG | Class II | |
| K910106 | Datascope Multinex Id Monitor | Datascope Corp. | CCK | Class II | |
| K905831 | Arzco Octapolar Esophageal Cardiac Record Cath | Arzco Medical Electronics, Inc. | DRF | Class II | |
| K905830 | Combo Fetal Scalp Electrode/legplate | Utah Medical Products, Inc | HGP | Class II | |
| K905617 | Visi-Staph | Connecticut Diagnostics, Ltd. | JWX | Class I | |
| K905604 | Visio-Gem Art-System | Espe GmbH (US) | EBF | Class II | |
| K905545 | Ultrasound Transmission Gel | Arbo Medical, Inc. | JOT | Class II | |
| K905481 | Northgate Technologies Model 7201 Insufflator | Northgate Technologies Inc. | HIF | Class II | |
| K905411 | Flowire and Flomap | Cardio Metrics, Inc. | DPW | Class II | |
| K905204 | Dw 236 | Ivoclar North America, Inc. | EJJ | Class II | |
| K905002 | Single Use Manual Resuscitators | Custom Medical, Inc. | BTM | Class II | |
| K904849 | Origineedle(tm) | Origin Medsystems, Inc. | FHO | Class II | |
| K904805 | Tentative Operating Name-Jazz Band | Franklin M. Din D.M.D., P.A. | EBF | Class II | |
| K904712 | Bc 1221 Ball Overdenture Attachment | Minimatic Implant Technology | DZE | Class II | |
| K904710 | Bc 1219 Healing Head | Minimatic Implant Technology | DZE | Class II | |
| K904459 | C544 Transducer | Acuson Corp. | ITX | Class II | |
| K903211 | O Butment | O Co., Inc. | DZE | Class II | |
| K903011 | Respitrace Plus, Respibands, and Respicentral | Non-Invasive Monitoring Systems, Inc. | BZQ | Class II | |
| K902324 | Tp and Design, Condom | China National Medicines & Health Prod. I/E Corp. | HIS | Class II | |
| K902305 | Trojan Naturalamb Natural Membrane Condom W/sperm. | Armkel, LLC | HIS | Class II | |
| K910914 | Surgical Tissue Pouch | Cook Incorporated | KGY | Class I | |
| K910655 | Combined Malar Implant | Implantech Associates Inc | LZK | Class II | |
| K910524 | Surgical Clipper | Baxter Healthcare Corporation | LWK | Class I | |
| K910493 | Avd Intimax Cholangiography Catheter | Applied Vascular Devices, Inc. | FGE | Class II | |
| K910369 | Incision and Drainage Kit | Megadyne Medical Products, Inc | KDD | Class I | |
| K910366 | Mega General Purpose Instrument Kit | Megadyne Medical Products, Inc | KDD | Class I | |
| K910365 | Wound Closure Kit | Megadyne Medical Products, Inc | LRO | Class II | |
| K910363 | Mega Dressing Change Kit | Megadyne Medical Products, Inc | MCY | Class II | |
| K905708 | Trimedyne Model 1210 Omnipulse Laser System | Trimedyne, Inc. | GEX | Class II | |
| K903986 | Swirl Prophylaxis Paste | Bio-Medica Concepts | EJR | Class I | |
| K910740 | Slt Microplate Washer | Tecan U.S. | JJQ | Class I | |
| K910361 | Suture Removal Kit | Megadyne Medical Products, Inc | MCZ | Class I | |
| K910308 | X-Ray Tube Housing Assembly Polarix II Gen/xo 110 | Inmark Corp. | ITY | Class I | |
| K910196 | Bard Hydrogel-Coated Diagnostic Urethral Catheters | C.R. Bard Inc | FGH | Class II | |
| K910164 | Orthoconcept Arthroscopic Pump | Orthoconcept, Inc. | HRX | Class II |