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 |
|---|---|---|---|---|---|
| K874146 | Titan Gel Rep Cpk-12 Hv | Helena Laboratories, Corp. | CGS | Class II | |
| K874117 | Medtronic Model 6550 Adjustable Hemostasis Valve | Medtronic, Inc. | DYG | Class II | |
| K874102 | Emds Procainamide Calibrator Item No. 67634/95 | Em Diagnostic Systems, Inc. | DLJ | Class II | |
| K873976 | Amerlite Tt4 Assay (240/480/144 Test Kits) | Amersham Corp. | KLI | Class II | |
| K873894 | Continu-Flo Solution W/check Valve 2 Y-Inject Site | Travenol Laboratories, S.A. | FPA | Class II | |
| K873610 | Pediatric Bubble Trap Cat. No. B-100 | American Omni Medical, Inc. | BSY | Class I | |
| K873561 | Electromedics D1079e | Electromedics, Inc. | DTR | Class II | |
| K873311 | Dale i.v. Connect. Lock & Stabilizer (Stabilok)220 | Dale Medical Products, Inc. | KMK | Class I | |
| K873201 | Wako(tm) Autokit Ck-Nac | FUJIFILM Healthcare Americas Corporation | CGS | Class II | |
| K873161 | Valleylab Model Iv7200 Infusion Pump | Medtronic, Inc. | FRN | Class II | |
| K873119 | Flexiflo Companion Enteral Nutrition Pump | Frantz Medical Development, Ltd. | LZH | Class II | |
| K872812 | Skinless-Skin, Pink Tint (Condom) | Okamoto U.S.A., Inc. | HIS | Class II | |
| K872664 | Skinless Skin-Harmony Condoms | Okamoto U.S.A., Inc. | HIS | Class II | |
| K874248 | Syntron Bioresearch U-Test Pregnancy Test | Syntron Bioresearch, Inc. | LCX | Class II | |
| K874185 | Dart (R) Electrolyte Reagent System | Coulter Electronics, Inc. | JGS | Class II | |
| K874153 | Easy-Test Phosphorus (Phos) Item No. 16687 | Em Diagnostic Systems, Inc. | CEO | Class I | |
| K874150 | Johnson Grass Allergen Disc | Incstar Corp. | DHB | Class II | |
| K874149 | False Ragweed Allergen Disc | Incstar Corp. | DHB | Class II | |
| K874141 | Titan Gel Rep Cpk/ldh Isoenzyme Control | Helena Laboratories, Corp. | JJT | Class I | |
| K874115 | No. 1000-H for Immunofluorometric Deter. of (Ana) | Sigma Diagnostics, Inc. | LKJ | Class II | |
| K874094 | 1205 Betaplate Liquid Scintillation Counter | Lkb Instruments, Inc. | JJJ | Class I | |
| K874066 | Surgical Caps | Interpro Intl., Inc. | FYF | Class I | |
| K874065 | Laparotomy Sponges | Interpro Intl., Inc. | EFQ | Unclassified | |
| K874064 | Shoe Covers | Interpro Intl., Inc. | FXP | Class I | |
| K873998 | Total Ige Fast (Tm) Test Package | 3M Company | DHB | Class II | |
| K873969 | Giant Ragweed Allergen Disc | Incstar Corp. | DHB | Class II | |
| K873741 | Immustrip(tm) Sm Elisa Test System | Immunomedics, Inc. | LKP | Class II | |
| K873730 | Medix Biotech Ferritin Enzyme Immunoassay Test Kit | Medix Biotech, Inc. | JMG | Class II | |
| K873451 | Project 300 Microassay Bp-12, Eia Minilab | Awareness Technology, Inc. | JJQ | Class I | |
| K873270 | Actinomycete Differential Media | Central Media | JSH | Class I | |
| K873269 | Mycological Media | Central Media | JSI | Class I | |
| K873268 | Mueller Hinton Media | Central Media | JTZ | Class II | |
| K873267 | ECG Based Media | Central Media | KZI | Class I | |
| K873185 | Dynabeads Hla Cell Prep II Isolation Product | Dynal Biotech, Inc. | JCF | Class I | |
| K873064 | Amtec Rheumatoid Factor Latex Agglutination Kit | Amtec Diagnostics International, Inc. | DHR | Class II | |
| K872869 | Stand. Clear Vinyl Disposable ECG Elect.(597 Adhe) | Labeltape Meditect, Inc. | DXH | Class II | |
| K872837 | Epicarida, Le | Medicomp, Inc. | DSI | Class II | |
| K872822 | Model 78576A Paper Chart Recorder | Hewlett-Packard Co. | DSF | Class I | |
| K872779 | Prolog Mp Pulse Generators 658K and 658T | Pacesetter Systems | DXY | Class III | |
| K872778 | Pacestart | Pacific Rim Engineering & Mfg. | DRO | Class II | |
| K872766 | Implantable Programmable Cardiac Pulse Generators | Telectronics, Inc. | DXY | Class III | |
| K872619 | Preventette (Condom) | Reb Enterprises, Inc. | HIS | Class II | |
| K864294 | Henke-Ject Pressure Syringe (Modification) | Smith & Nephew, Inc. | EGM | Class II | |
| K862947 | The Expert Models Rts 2000 and Rts 2000H | Ocg Technology, Inc. | DSI | Class II | |
| K874249 | Bifurcated Needle | Allergy Laboratories of Ohio, Inc. | FMI | Class II | |
| K874244 | Dynatech Mr 300 Manual Microelisa | Dynatech Laboratories, Inc. | JJQ | Class I | |
| K874229 | Anatomic Total Hip | Zimmer GmbH | JDI | Class II | |
| K874140 | Titan Gel Rep Simultaneous Ck-Ld Isoenzyme Proced. | Helena Laboratories, Corp. | CGS | Class II | |
| K874139 | Titan Gel Rep Cpk-30 Hv | Helena Laboratories, Corp. | CGS | Class II | |
| K874061 | Tsh Enzyme Immunoassay Test Kit No. Mb-1093 | Medix Biotech, Inc. | JLW | Class II |