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 |
|---|---|---|---|---|---|
| K963470 | Criss-Cross Vest Restraint | DeRoyal Industries, Inc. | FMQ | Class I | |
| K963469 | Mittens | DeRoyal Industries, Inc. | FMQ | Class I | |
| K963413 | Multiple Limb Holders | J. T. Posey Co. | FMQ | Class I | |
| K963409 | Posey Hugger | J. T. Posey Co. | FMQ | Class I | |
| K963394 | Osteomed Tram | Osteomed | JEY | Class II | |
| K963350 | Depuy Motech Peak Fixation System | Depuy, Inc. | HWC | Class II | |
| K963313 | Exactech All Poly Acetabular Cup | Exactech, Inc. | JDI | Class II | |
| K963250 | Pressure Valve | Respironics, Inc. | BZD | Class II | |
| K963242 | Duracon Posterior Femoral Spacer | Howmedica Corp. | JWH | Class II | |
| K963241 | Ultraflex | Boston Scientific Corporation | JCT | Class II | |
| K963224 | Steri-Oss Implants for Single Stage Placement | Steri-Oss, Inc. | DZE | Class II | |
| K963215 | Clampless Valved Catheter - Midline (Cvc-Ml) | Bmw Medical, Inc. | LJS | Class II | |
| K962913 | Synthes Sterile Drill Bits | Synthes (USA) Products LLC | HWE | Class I | |
| K961740 | Kodak Digital Science Medical Printer Interface Unit | Kodak Health Imaging Systems, Inc. | LLZ | Class II | |
| K961739 | Kodak Digital Science Medical Modality Acquisition Unit | Kodak Health Imaging Systems, Inc. | LLZ | Class II | |
| K960868 | B.a.s.i.c. Dental Implant System | Danlin Products, Inc. | DZE | Class II | |
| K960652 | Bioscrew Absorbable Interference Screw | Linvatec Corporation | HWC | Class II | |
| K952827 | Full Auto Wrist Blood Pressure Meter Model Se-5000 | Sein Electronics Co., Ltd. | DXN | Class II | |
| K952826 | Full Auto Fuzzy Blood Pressure Meter Model Se-7000 | Sein Electronics Co., Ltd. | DXN | Class II | |
| K964204 | Engstrom Hmef 1000 | Datex-Engstrom, Inc. | CAH | Class II | |
| K963800 | Il Synthesis | Instrumentation Laboratory Co. | CHL | Class II | |
| K963682 | Genie' Single Ceiling and Double Ceiling | Burton Medical Products Corp. | FSY | Class II | |
| K963432 | Guide Wires for Cannulated Screws | Orthopaedic Biosystems, Ltd. | LXT | Class II | |
| K963288 | Lm Bone Anchor | Li Medical Technologies, Inc. | MBI | Class II | |
| K963214 | Cordis St Steerable Guidewire | Cordis US Corp. | DQX | Class II | |
| K963210 | Vail 100 Pediatric Crib | Vail Products, Inc. | FMS | Class II | |
| K963193 | Accu-Beam Laser Block 301513Bg385/beam Splitters 301513Bg39 | Transamerican Technologies Intl. | GEX | Class II | |
| K962821 | Epidural Anesthesia Kit and Combined Spinal Epidural Anesthesia Kit | Global Medical Products, Ltd. | CAZ | Class II | |
| K962706 | Ez-Fix Cannulated Screw System | Biodynamic Technologies, Inc. | HWC | Class II | |
| K962038 | Pes Hot/cold Compress | Princeton Electronic Systems, Inc. | IRT | Class II | |
| K961605 | Karl Storz 10.5 Fr. Flexible Hysteroscope | Karl Storz Endoscopy-America, Inc. | HIH | Class II | |
| K961520 | Unipolar Ipg Ground Cable, Model 5473 | Medtronic, Inc. | LDF | Class II | |
| K964268 | Triad 88 Nuclear Imaging System | Trionix Research Laboratory, Inc. | KPS | Class II | |
| K964267 | Monad Nuclear Imaging Single Photon Emission Computed Tomography System | Trionix Research Laboratory, Inc. | KPS | Class II | |
| K964266 | Biad Nuclear Imaging System | Trionix Research Laboratory, Inc. | KPS | Class II | |
| K964265 | Cardiac Triad Nuclear Imaging Single Photon Emission Computed Tomography System | Trionix Research Laboratory, Inc. | KPS | Class II | |
| K963921 | Pulpdent Seal-Rite Udma | Pulpdent Corporation | EBC | Class II | |
| K963905 | Radiographic Itt Table | X-Ray Technologies, Inc. | KXJ | Class II | |
| K963812 | Lm Bone Anchor (Orthopedics) | Li Medical Technologies, Inc. | MBI | Class II | |
| K963656 | Foam Calcium Aliginate Topical Wound Dressing | Adri | KMF | Class I | |
| K963618 | Synthes Simple Small External Fixator (Ssef) | Synthes (USA) Products LLC | LXT | Class II | |
| K963492 | Protective Restraint | Smith and Nephew Donjoy, Inc. | FMQ | Class I | |
| K963490 | Protective Restraint - Belts | Smith and Nephew Donjoy, Inc. | FMQ | Class I | |
| K963489 | Wheel Chair Accessory | Smith and Nephew Donjoy, Inc. | FMQ | Class I | |
| K963477 | Pediatric Mittens | DeRoyal Industries, Inc. | FMQ | Class I | |
| K963464 | Restraint Net | DeRoyal Industries, Inc. | FMQ | Class I | |
| K963309 | Apex Hole Eliminator Ps | Depuy, Inc. | LPH | Class II | |
| K963186 | Ortho 8000 | Inner Vision Mri, Ltd. | LNH | Class II | |
| K963169 | Rapid-Aid Therapeutic/scanning Ultrasound Gel | Rapid-Aid Ltd./Ltee | ITX | Class II | |
| K963162 | Quantem | Elscint, Inc. | KPS | Class II |