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 |
|---|---|---|---|---|---|
| K935898 | Hydrogum | Zhermack Dental Production | ELW | Class II | |
| K924408 | Colla-Tec Absorbable Collagen Membrane | Colla-Tec, Inc. | LYC | Class II | |
| K953658 | Corssfire Plus | Cardiogenes | GEX | Class II | |
| K953618 | Spyroflex Wound Dressing | Polymedica Industries, Inc. | MGP | Unclassified | |
| K953549 | Ksea Extraction Bag | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K953425 | Polyethylene Terephthalate (Pet) Pledget | Davis & Geck, Inc. | DXZ | Class II | |
| K953289 | Tetrafluoroethylene (Tfe) Polymer Pledget | Davis & Geck, Inc. | DXZ | Class II | |
| K953195 | Valleylab Force 300 | Medtronic, Inc. | GEI | Class II | |
| K953067 | Hip Fracture Stem Fenestration Plug | Howmedica Corp. | JDG | Class II | |
| K953007 | Excalibur Plus Electrosurgical Unit | Aspen Laboratories, Inc. | GEI | Class II | |
| K952874 | Transit Infusion Catheter | Cordis Neurovascular, Inc. | KRA | Class II | |
| K952677 | Medpor Barrier Surgical Implant Biomaterial | Porex Surgical, Inc. | FWP | Class II | |
| K952394 | Playtex Tampons #13695 | Playtime Products, Inc. | HEB | Class II | |
| K952348 | Ogden Anchor | American Medical Electronics, Inc. | JDR | Class II | |
| K952270 | Dideco Adult Arterial Filters D732 Micro 20 W/20, D734 Micro 40 W/40 Micron Screen | Sorin Biomedical, Inc. | DTM | Class II | |
| K951794 | Synthes (USA) Univ. Screw Fixation System (Titanium) | Synthes (USA) Products LLC | MNH | Class II | |
| K951729 | Medi - Pump | Thomas Industries | BTA | Class II | |
| K951657 | Vsp (Variable Screw Placement) Spinal Fixation System, Pedicle Screw(s), Spine Plate(s), Washer(s) & Nut(s) | Acromed Corp. | MNH | Class II | |
| K951626 | Synthes (u.s.a.) Universal Spinal Hook, Rod and Pedicle/sacral Screw Fixation System | Synthes (USA) Products LLC | MNH | Class II | |
| K951520 | Ussc Polysorb Suture | United States Surgical, A Division of Tyco Healthc | GAM | Class II | |
| K945285 | Ussc Monofilament Polysorb Suture | United States Surgical, A Division of Tyco Healthc | GAM | Class II | |
| K942435 | Saliva Sampler | Saliva Diagnostic Systems, Inc. | PJD | Class II | |
| K953441 | Riza-Ribe Needle | R-Med, Inc. | FBK | Class II | |
| K953374 | Permadyne Garant 2:1 | Espe GmbH & Co. KG. | ELW | Class II | |
| K953232 | Hollister Nasogastric Tube Attachment Device | Hollister, Inc. | KNT | Class II | |
| K953024 | Lindner/golomb Sp Introducing Sound | Cook Incorporated | KOB | Class II | |
| K952924 | Adi Catheter with Valve | Asia Dynamics Inc. | GBM | Class II | |
| K952887 | Noprofile Olbert Catheter System Balloon Dilatation Catheter | Meadox Medicals, Div. Boston Scientific Corp. | LJE | Unclassified | |
| K952841 | The Assistant | CooperSurgical, Inc. | FHA | Class I | |
| K952828 | Medi-Tech Percutaneous Introducer System | Boston Scientific Corporation | DYB | Class II | |
| K952760 | Fixed Flow Rate Gravity Administration Sets | Halyard Health | FPA | Class II | |
| K952740 | Depuy Duraloc 400 Acetabular Cup | Depuy, Inc. | LPH | Class II | |
| K952693 | Ramitec Penta | Espe GmbH & Co. KG. | ELW | Class II | |
| K952671 | Ratesaver Plus | Entracare Corp. | LZH | Class II | |
| K952430 | Finesse Guidewire Coronary | Flexmedics | DQX | Class II | |
| K952296 | Synthes (USA) [Synthes[ Self-Drilling Schanz Screw | Synthes (USA) Products LLC | HWC | Class II | |
| K952240 | Tooth Preparation Conditioner, Pre-Impression | Jeneric/Pentron, Inc. | EBC | Class II | |
| K952216 | Slt Multidimensional Contact Laser System & Wce Diffuser Flat Probe Df 2 | Surgical Laser Technologies, Inc. | GEX | Class II | |
| K951735 | Joerns Healthcare, Inc. Full Length Telescoping Rail | Joerns Healthcare | FNL | Class II | |
| K951623 | Tlc Surgical Gowns | Tlc Tech Lab Clothes, Inc. | FYA | Class II | |
| K951474 | Tlc Surgical Drapes | Tlc Tech Lab Clothes, Inc. | KKY | Class II | |
| K951413 | Fogarty-Hydragrip Surgical Clamps | Baxter Healthcare Corporation | DXC | Class II | |
| K951404 | R&d Batteries Part Nos. 5096, 5115, 5128 and 5131 | R & D Batteries, Inc. | FLL | Class II | |
| K951403 | R&d Batteries Part Nos. 5164, 5252, 5634 and 5650 | R & D Batteries, Inc. | FLL | Class II | |
| K951402 | R&d Batteries Part Nos. 5167, 5221, 5244 and 5247 | R & D Batteries, Inc. | FLL | Class II | |
| K951401 | R&d Batteries Part Nos. 5015, 5016, 5037 and 5051 | R & D Batteries, Inc. | FLL | Class II | |
| K951400 | R&d Batteries Part Nos. 5064, 5157, 5489 and 5536 | R & D Batteries, Inc. | FLL | Class II | |
| K951399 | R&d Batteries Part Nos. 5041 & 5655 | R & D Batteries, Inc. | FLL | Class II | |
| K951285 | R&d Batteries, Inc. Part Numbers 5158, 5168, 5171 and 5172 | R & D Batteries, Inc. | FLL | Class II | |
| K951284 | R&d Batteries, Inc. Part Numbers 5137, 5140, 5142 and 5155 | R & D Batteries, Inc. | FLL | Class II |