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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K884116 | Type 9040 System Athena | S & W Medico Teknik | DPS | Class II | |
| K883317 | Dcd-1 (Digital Contour Detect-Radiat Therapy) Syst | S & S X-Ray Products, Inc. | IXI | Class II | |
| K883011 | MRI Neo-Tryp Trypsin Ria | Microbiological Research Corp. | JNO | Class I | |
| K892262 | Fresenius Hemoflow, F40m, F50m, F60m & F80m | Fresenius USA, Inc. | KDI | Class II | |
| K892115 | Protex Patient Examination Gloves (Latex) | Pt Nusa Dipa Perdana | LYY | Class I | |
| K892096 | Patient Examination Glove (Latex) | Grand Universe Trading Co., Ltd. | LYY | Class I | |
| K892000 | Flexible Immersible Sigmoidoscope | Schott Fiber Optics, Inc. | FAM | Class II | |
| K891871 | Phaser (Single Linear Mechanical Massage) | Monad Corp. | ISA | Class I | |
| K891704 | Patient Examination Gloves (Latex) | Executive Commodities Exchange Co. | LYY | Class I | |
| K891646 | Toplas Vinyl Patient Examination Glove | Toplas Industrial Co., Ltd. | LYZ | Class I | |
| K891645 | Tak, Vinyl Patient Examination Gloves | Tak Ent., Inc. | LYZ | Class I | |
| K891344 | Olive Brand, Silky Touch Patient Examination Glove | Uni-Attach, Inc. | LYY | Class I | |
| K891343 | Giglo Patient Examination Glove (Latex) | Giant Glove Industrial Co., Ltd. | LYY | Class I | |
| K891258 | Patient Examination Gloves (Latex) | Aek Rubber Product Sdn. Bhd. | LYY | Class I | |
| K890869 | Bard Hysterosalpingography Catheters | C.R. Bard Inc | HES | Class II | |
| K890851 | Patient Examination Gloves (Non-Sterile Vinyl) | Daw Shin Industrial Co., Ltd. | LYZ | Class I | |
| K890740 | Frs Lite Fluoride Releasing Sealant | Ormco Corp. | DYH | Class II | |
| K890712 | Advantage Dental Cust Dent Impress/baseplate Trays | Advantage Dental Products, Inc. | EBH | Class I | |
| K890706 | Cytobrush | Laboratoire Ccd C/O Washington Regulatory Services | HHT | Class II | |
| K890654 | New Freedom Thin Super & Unscented, Maxi & Super | Kimberly-Clark Corporation | HHD | Class I | |
| K890013 | Kotex Super Maxi Pads | Kimberly-Clark Corporation | HHT | Class II | |
| K884454 | Safecon Condoms - Ribbed | Quality Synthetics Intl, Inc. | HIS | Class II | |
| K884325 | Subclavian Hemodialysis Cath. W/vitacuff Device | BD Becton Dickinson Vacutainer Systems Preanalytic | FOZ | Class II | |
| K884322 | Subclavian Hemodialysis Catheter | BD Becton Dickinson Vacutainer Systems Preanalytic | LFJ | Class II | |
| K884304 | Ortho Patient Chair | Halton Furniture Mfg. | KLC | Class I | |
| K884122 | Type 9320 Cardiac Output System Athena | S & W Medico Teknik | DXG | Class II | |
| K884121 | Type 9266 Sao2 System Athena | S & W Medico Teknik | DQA | Class II | |
| K884118 | Type 9220 Press 1 & 2 System Athena | S & W Medico Teknik | DSK | Class II | |
| K892343 | Suction Control Valve | Concord/Portex | BSY | Class I | |
| K891345 | Mobilimb Cpm Shoulder Unit | Toronto Medical Corp. | BXB | Class I | |
| K891267 | Patient Examination Gloves (Latex) | Genie Rubber Products Co. | LYY | Class I | |
| K890420 | Usci 7F Guide Catheter | C.R. Bard Inc | DQO | Class II | |
| K885146 | Cl Universal Hip Device | Lima Intl. Corp. | KWI | Class II | |
| K882980 | Rebuilder Bucket System | MicroMed, LLC | GZJ | Class II | |
| K881164 | Leunomed Rfb 5000 | Hemodynamics, Inc. | HCC | Class II | |
| K892231 | V-Trend Target Crp Test | Texas Immunology, Inc. | DCN | Class II | |
| K892004 | Liquichek(r) Serum Alcohol Control; Levels 1,2 & 3 | Bio-Rad | LAS | Class I | |
| K891370 | Edl One-Stage Prothrombin Time Reagent | Elite Diagnostic, Ltd. | GJS | Class II | |
| K891337 | Thromboscreen Aptt Reagent | Pacific Hemostasis | GFO | Class II | |
| K891072 | Intravascular Administration Set | Multi-Med, Inc. | FPA | Class II | |
| K890859 | Edl Global Activated Partial Thromboplastin Time | Elite Diagnostic, Ltd. | GFO | Class II | |
| K890775 | Infralase - Laserguide Delivery System | Ximed Medical Systems | GEX | Class II | |
| K890751 | Acci-Guard(tm) i.v. Catheter Placement Unit | Medical Safety Products, Inc. | FOZ | Class II | |
| K890634 | Berichrom Protein C Kit | Behring Diagnostics, Inc. | GGP | Class II | |
| K890633 | Enzygnost Platelet Factor 4 (Pf4) Kit | Behring Diagnostics, Inc. | LCO | Class II | |
| K890527 | Alternate Packaging Configuration for Pacing Leads | Medtronic, Inc. | DTB | Class III | |
| K890522 | Puritan Bennett Pb900a Diagnostic Spirometer | Medtronic, Inc. | BZG | Class II | |
| K890518 | Single Lumen S.e.a.-Port Vascular Access System | Harbor Medical Devices, Inc. | LJT | Class II | |
| K890484 | Hi-Lo Temp General Purpose Temperature Probe | Mallinckrodt Anesthesia Products | FLL | Class II | |
| K890466 | Sigmoid Tonomitor | Tonometrics, Inc. | GBT | Class II |