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 |
|---|---|---|---|---|---|
| K945094 | Hnr-Pc Hip | Howmedica Corp. | LZO | Class II | |
| K945093 | P.c.a. E-Series Hip- Cementless Use | Howmedica Corp. | LZO | Class II | |
| K945092 | P.c.a.primary Hip- Cementless Use | Howmedica Corp. | LZO | Class II | |
| K945090 | Howmedica Zirconia Ceramic Femoral Head | Howmedica Corp. | LZO | Class II | |
| K945089 | Sentry Total Hip | Howmedica Corp. | LZO | Class II | |
| K943017 | Neonatal Restraint and Comfort Systems | K.Bowmed, Inc. | FRP | Class I | |
| K942299 | Endocare Cryotherapy System | Cytocare, Inc. | GEH | Class II | |
| K940519 | Dideco Compact-a Autotransfusion System | Dideco S.p.A. | CAC | Class II | |
| K940389 | S.t.e.p. Uni-Knee | S.T.E.P. Orthopaedics, Inc. | HRY | Class II | |
| K940307 | Howmedica Straight Stem Femoral Component | Howmedica Corp. | JDI | Class II | |
| K935958 | Crit-Line Blood Chamber with E-Beam | In-Line Diagnostics Corp. | KOC | Class II | |
| K934917 | Resound Personal Hearing Systems Modification | Resound Corp. | ESD | Class I | |
| K950005 | Trocar Cannula Stabilizer | Advanced Surgical, Inc. | GCJ | Class II | |
| K946164 | Ks Semi-Rigid Micro-Endoscopes and Accessories for Adult and Pediatric General Endospocic and Laparoscopic Surgical Pros | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K945952 | Vacutainer(r) Brand Plus Pst(tm) Plasma Separation Tube | BD Becton Dickinson Vacutainer Systems Preanalytic | JKA | Class II | |
| K945842 | Mobilix Mobile X-Ray Table | GE Healthcare | IXR | Class II | |
| K945560 | Urotek Laser Catheter | Energy Life Systems Corp. | GEX | Class II | |
| K945556 | Anterior/posterior Epistaxis Catheter | Ultracell Medical Technologies, Inc. | EMX | Class I | |
| K945395 | Premier Mirror Warmer | Premier Dental Products Co | ETF | Class I | |
| K945381 | Nasopharyngoscopes, Bronchoscopes, Tracheoscp[es and Esophagoscopes, Laryngoscopes, Oto-Telescopes | Karl Storz Endoscopy-America, Inc. | EOB | Class II | |
| K945170 | Quik-Stitch | Coral Medical, Inc. | GCJ | Class II | |
| K945126 | Eclipse 3200 | Cardiogenes | GEX | Class II | |
| K945091 | Howmedica Alumina Femoral Head | Howmedica Corp. | LZO | Class II | |
| K944980 | Sound Selector Ite (Ssi), Bte (Ssb), Mini Bte( Ssm) | Hearing Solutions, Inc. | ESD | Class I | |
| K944613 | Shoulder Retractor | Northwest Medical Physics Center | KPR | Class II | |
| K944399 | Medi-Pump | Thomas Industries | BTA | Class II | |
| K944110 | Vicryl Rapide Suture | Ethicon, Inc | GAM | Class II | |
| K943981 | Il Test Phenobarbital Calibrators | Instrumentation Laboratory Co. | DLZ | Class II | |
| K943979 | Il Test Theophylline | Instrumentation Laboratory Co. | KLS | Class II | |
| K943932 | Steriseal Ophthalmic Cannula | Pharma-Plast, Ltd. | HMX | Class I | |
| K942862 | Heartprint | Medata, Inc. | DSH | Class II | |
| K941651 | Cts Relief Kit | Linvatec Corporation | HRX | Class II | |
| K941222 | Open Laparoscopy Trocar Cone System | Richard Wolf Medical Instruments Corp. | GCJ | Class II | |
| K936274 | Kirschner Performance Posterior Stabilized Total Knee System | Kirschner Medical Corp. | JWH | Class II | |
| K936178 | Agilance-Golden Spoons | Oismuller & Partner Keg | ISA | Class I | |
| K935853 | EMG Trainer | Unitech | HCC | Class II | |
| K930836 | Howmedica(r) Mono-Tube(tm) External Fixator System | Howmedica Corp. | KTT | Class II | |
| K922979 | Sterile Extra Protecion Surgeon's Gloves | Ansell Malaysia Sdn Bhd | KGO | Class I | |
| K946256 | Sunglasses | Chanel, Inc. | HQY | Class I | |
| K946231 | Eye Cooler | Direct Import Marketing Co. | HQY | Class I | |
| K946184 | Cedia(r) Folate (No Boil) Assay | Microgenics Corporation | CGN | Class II | |
| K946155 | Latex Examination Glove, Patient (Powder-Free) | Mala Intertrade Co., Ltd. | LYY | Class I | |
| K946132 | Proway | Union Industrial Co., Ltd. | HQY | Class I | |
| K946126 | Pasco Mic and Mic/id Panels | Pasco Laboratories, Inc. | JWY | Class II | |
| K946090 | Kodak Ektacchem 950Irc Analyzer | Clinical Diagnostic Systems, Inc. | JJE | Class I | |
| K946059 | Cedia(r) Dau Pcp Assay | Microgenics Corporation | LCM | Unclassified | |
| K945925 | Eyewear/spectacles | Kovision Mfg., Ltd. | HQY | Class I | |
| K945920 | Sunglasses | Glendale Protective Technologies, Inc. | HQY | Class I | |
| K945860 | Spectrum Co-Oximeter Linearity Control | Phoenix Diagnostics, Inc. | JJS | Class I | |
| K945833 | Elastyren(r) Surgical Gloves | Eci Medical Technologies, Inc. | KGO | Class I |