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 |
|---|---|---|---|---|---|
| K982453 | Non-Sterile E.p. Latex Examination Glove | Ansell Perry | LYY | Class I | |
| K982241 | Betatrans Intraop I and II Model Numbers Ds100x and Ds10xx | Duxbury Scientific, Inc. | CAC | Class II | |
| K982218 | Nitrile Powder-Free Uniseal Gloves | American Healthcare Products (M) Sdn Bhd | LZA | Class I | |
| K982170 | Fluidsense Fluid Delivery System | Fluidsense Corp. | FRN | Class II | |
| K982059 | Rotecno 2000 Surgical Gown | Encompass Group LLC | FYA | Class II | |
| K981979 | Uniseal Gloves Low Protein Powdered | American Healthcare Products (M) Sdn Bhd | LYY | Class I | |
| K983681 | Dominator | Impact Wheelchair Manufacture, Inc. | IOR | Class I | |
| K983108 | Suture Welding System and Kit (Swk) | TORNIER Inc. | GAW | Class II | |
| K983066 | Firstclass Power Tilt Seat System, Model S300 | Teftec Corp. | ITI | Class II | |
| K984073 | Architect Total P-Hcg Mastercheck, List No. 6C21-05 | Bio-Rad | JJX | Class I | |
| K984070 | Architect Free T4 Mastercheck, List No. 6C50-05 | Bio-Rad | JJX | Class I | |
| K983970 | Immulite Myoglobin, Model Lkmy1 and Lkmy5 | Siemens Healthcare Diagnostics Inc. | DDR | Class II | |
| K983963 | Dornier Medila H | Dornier Medtech America, Inc. | GEX | Class II | |
| K983913 | Modification to Bio-Logic Sleepscan | Bio-Logic Systems Corp. | OLV | Class II | |
| K983910 | Arthro-Surgimat-1500 | Novanta Medical GmbH | HRX | Class II | |
| K983895 | Immage Immunochemistry System Beta-2 Microglobulin Reagent | Siemens Healthcare Diagnostics Inc. | JZG | Class II | |
| K983859 | Spectrum Small Fry | Freedom Designs Inc | IOR | Class I | |
| K983788 | Aaron Coolpad Split W/o Cord,aaron Coolpad Split with Cord, Aaron Coolpad W/o Cord, Arron Coolpad with Cord, Models Esre | Apyx Medical Corporation | GEI | Class II | |
| K983726 | Glypro Reagent, Glypro Calibrator, Glypro Low Control, Glypro High Control | Genzyme Corporation | LCP | Class II | |
| K983469 | Preciset Serum Proteins Calibrator | Boehringer Mannheim Corp. | JIX | Class II | |
| K983440 | Abbott Architect Total T4 | Abbott Medical | KLI | Class II | |
| K983419 | Hoffmann II Miami Post | Howmedica Corp. | HRS | Class II | |
| K983386 | Biostrep a-Direct Strep a Antigen Test | Princeton BioMeditech Corp. | GTY | Class I | |
| K983384 | Dci Endoscope | Karl Storz Endoscopy-America, Inc. | HRX | Class II | |
| K983301 | Sensititre 18-24 Hour Susceptibility Plates with Trovafloxacin | Accumed Intl., Inc. | JWY | Class II | |
| K983291 | Solo-Care Brand Multi-Purpose Solution | Alcon Laboratories | MRC | Class II | |
| K983278 | Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear Contact Lens (Sighted an Non-Sighted Eyes) | Alden Optical Labs., Inc. | LPL | Class II | |
| K983259 | System U3 for Trimethoprim/sulfamethoxazole | Ab Biodisk | JWY | Class II | |
| K983249 | Sureskin Plus Standard, Sureskin Plus Border, Sureskin Plus Thin | Euromed, Inc. | FRO | Unclassified | |
| K983234 | Tielle Plus Hydropolymer Adhesive Dressing | Johnson & Johnson Medical, Div. of Ethicon, Inc. | MGP | Unclassified | |
| K983150 | Complete Brand Lubricating and Rewetting Drops | Allergan | LPN | Class II | |
| K983136 | Depuy Luster Stem | Depuy Orthopaedics Inc. | JDI | Class II | |
| K983076 | Medisystems Transducer Protector | Medisystems Corp. | FIB | Class II | |
| K983050 | Pneumatic Cutter System | Surgical Laser Technologies, Inc. | ERL | Class II | |
| K983045 | Amielle | Owen Mumford USA, Inc. | KXP | Class II | |
| K983042 | Sween Woun'dres | MEDLINE INDUSTRIES, LP - Northfield | MGQ | Unclassified | |
| K983020 | Compact Ktp Laser | Cosmos Medical Technology | GEX | Class II | |
| K983009 | Bsm- Bone Substitute Material | Etex Corp. | GXP | Class II | |
| K983008 | Peripheral Ave Stent System | Peripheral Ave | FGE | Class II | |
| K983004 | Consensus Femoral Component, Porous, Cocr/ti | Hayes Medical, Inc. | JWH | Class II | |
| K982711 | Premier Giardia | Meridian Diagnostics, Inc. | MHI | Class II | |
| K982447 | Plus Bipolar Prosthesis Cocrmo | Plus Orthopedics | KWY | Class II | |
| K982352 | Vca Igm Elisa Test System | Columbia Bioscience, Inc. | LSE | Class I | |
| K982350 | Ea-D Igm Elisa Test System | Columbia Bioscience, Inc. | LSE | Class I | |
| K982348 | Ebna-1 Igm Elisa Test System | Columbia Bioscience, Inc. | LSE | Class I | |
| K982322 | Synthes Spine Occipital-Cervical Plate/rod and Hook System | Synthes (USA) Products LLC | KWP | Class II | |
| K982280 | Cryopro Maxi and Cryopro Mini | Cortex Technology ApS | GEH | Class II | |
| K982104 | Escort-Link Central Station Monitor Model 20500 | Medical Data Electronics | MLD | Class II | |
| K982027 | Modification to Copalis Cmv Total Antibody Assay | Diasorin Inc. | LFZ | Class II | |
| K981976 | Acutron Mentor Model 961 | Microcurrent Research, Inc. | GZJ | Class II |