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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K862707 | Emds(tm) Cholesterol Testpack, # 67685/95 | Em Diagnostic Systems, Inc. | CHH | Class I | |
| K862706 | Emds(tm) Triglyceride Testpacks #67674/95 | Em Diagnostic Systems, Inc. | CDT | Class I | |
| K862704 | Emds(tm) Elevated Bilirubin Calibrator # 67627/95 | Em Diagnostic Systems, Inc. | JIS | Class II | |
| K862701 | Surespot | Helena Laboratories, Corp. | JQW | Class I | |
| K862700 | Seratest Ena [Ss-B] Kit | Hemagen Diagnostics, Inc. | LLL | Class II | |
| K862603 | Double Antibody Estradiol Ria Kit | Siemens Healthcare Diagnostics Inc. | CHP | Class I | |
| K862594 | Seracon(tm) Cal (Product No. Do35) | Bhp Diagnostix, Inc. | JIX | Class II | |
| K862525 | Emds(tm) Dichrome Qc Test Solution Item # 67447/95 | Em Diagnostic Systems, Inc. | JIT | Class II | |
| K862453 | Emds Theophylline Calibrators Item No. 67---/93 | Em Diagnostic Systems, Inc. | JIS | Class II | |
| K862439 | Sucrosep Follicle Stimulating Hormone (Fsh) Irma | Boots-Celltech Diagnostics, Inc. | CGJ | Class I | |
| K862428 | Stratus Tsh Fluorometric Enzyme Immunoassay | American Dade | JLW | Class II | |
| K862364 | Needle Guide (for Ultrasound Transducers) | Swemed Laboratories, Inc. | HEM | Class II | |
| K862359 | Meth./cali./intru. Check for the Dimension System | E.I. Dupont de Nemours & Co., Inc. | CIG | Class II | |
| K862357 | Modified Cardiotomy Reservoir 5M1470 | 3M Health Care, Sarns | DTN | Class II | |
| K862355 | Trans-Pulse Model #1103 | The Sun Co. | GZJ | Class II | |
| K862320 | Difco Chlamydia Direct Detection System | Difco Laboratories, Inc. | LJP | Class I | |
| K862306 | King Diagnostics Ldh Test | King Diagnostics, Inc. | CFJ | Class II | |
| K862288 | Modification of Tissue Dilator | Quinton, Inc. | DRE | Class II | |
| K862266 | Maple Allergen Disc | Immuno Nuclear Corp. | DHB | Class II | |
| K862227 | Model 8 & 20 Argon Laser for Pelvic Surgery in Gyn | Hgm, Inc. | HHR | Class II | |
| K862184 | Dako Ita, Immunoglobulin M (Igm) | Dako Corp. | DAH | Class II | |
| K862183 | Dako Ita, Immunoglobulin a (Iga) | Dako Corp. | CZP | Class II | |
| K862115 | Dekna Band Kit | Deknatel, Inc. | ITG | Class I | |
| K862108 | Enzymun-Test Hcg | Boehringer Mannheim Corp. | DHA | Class II | |
| K861970 | Lyphochek Urine Toxicology Control | Bio-Rad | DIF | Class I | |
| K861966 | Modified Ideia Chlamydia Test | Boots-Celltech Diagnostics, Inc. | LJC | Class I | |
| K861697 | Self Assure/ghb (Capillary-Blood Collection Kit) | Awareness Technology, Inc. | LCP | Class II | |
| K861623 | Model 3000 Mlultichannel Fluoroptic Thermometer | Luxtron | FLL | Class II | |
| K861508 | Wako Micro Tp | FUJIFILM Healthcare Americas Corporation | CEK | Class II | |
| K860909 | Worlds Best and Worlds Best Extra Series (Condoms) | U. C. Import & Co. | HIS | Class II | |
| K860823 | Elsa-Prol Immunoradiometric Assay Kit | Cis-Us, Inc. | CFT | Class I | |
| K860462 | Seamed Model 3000 | Seamed Corp. | DTC | Class II | |
| K860325 | Pristine Culture Catheter | Hall/Mccollum Laboratories, Inc. | KOD | Class II | |
| K862933 | Abc-1000 Small Joint Reamers | Instrumentation Industries, Incorporated | HTO | Class I | |
| K862776 | Spectrum Polycord I Recorder System | Cardionics, Inc. | DSH | Class II | |
| K862772 | V. Mueller (R) Gooseneck Circular Stapler | American V. Mueller | GAG | Class II | |
| K862675 | Modified Deodorant Maxithins Panty Shields | Tambrands Inc. | HHL | Class II | |
| K862647 | Physiological Monitor, Models 401,402 & 403 | Ivy Biomedical Systems, Inc. | DSK | Class II | |
| K862564 | A.c.l. Guide Kit | Aspen Laboratories, Inc. | FZX | Class I | |
| K862499 | Ultracast | Ultratek | EJH | Class II | |
| K862490 | Anu-Rx | J. & Jp., Inc. | LKX | Unclassified | |
| K862337 | Ultrapac II Sd (Tm) | Medical Devices Inc. | GZJ | Class II | |
| K862292 | Espe Visio-Molar | Espe GmbH (US) | EBF | Class II | |
| K862202 | Vision(tm) Hemoglobin | Abbott Medical | KHG | Class II | |
| K862166 | Sonoranger | Ausonics Pty, Ltd. | IYO | Class II | |
| K862161 | Osc-80 Oximeter | Waters Instruments, Inc. | DQA | Class II | |
| K861586 | Lopez Valve | Abbott Medical | MJF | Class II | |
| K861494 | Empty Solution Transfer Container 1,500 Ml | Polymer Technologies | KNT | Class II | |
| K861092 | Model Sp1465 Cardiac Output Computer | Gould, Inc. | DXG | Class II | |
| K860968 | Tm-3400, Nomad (Modified) | Tracor Northern, Inc. | GWF | Class II |