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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K780792 | Testosterone Radioimmunoassay Kit 125I | The Upjohn Co. | CDZ | Class I | |
| K780791 | Sgpt/alt Reagent System | American Monitor Corp. | CKA | Class I | |
| K780789 | Peralistic Pump Model 2000 | Innovative Medical Systems, Inc. | JQW | Class I | |
| K780735 | Urinary Catheter Care Set | Shield Laboratories, Inc. | FCM | Class II | |
| K780726 | Tsh Ria Kit | Amersham Corp. | JLW | Class II | |
| K780668 | Solutions for Respiratory Therapy | Travenol Laboratories, S.A. | CAF | Class II | |
| K780659 | Hdl Cholesterol | Macomb Chemical Co. | CHH | Class I | |
| K780433 | Fiber Optic Adjustable Headlight | Cameron-Miller, Inc. | FCT | Class II | |
| K780258 | Milk Bath Concentrate | Sparta Instrument Corp. | |||
| K780805 | S/d 600 Sphygmomanometer and Pulsemeter | G & W Applied Science Laboratories | DXN | Class II | |
| K780803 | Till-U-Test, Dip Slide | Biotron, Ltd. | JXA | Class I | |
| K780800 | Electronic Thermometer | Metek Corp. | FLL | Class II | |
| K780795 | Gauze Sponges | Abco Dealers, Inc. | NAB | Class I | |
| K780787 | Triiodothyronine Radioimmunoassay Kit | BD Becton Dickinson Vacutainer Systems Preanalytic | CDP | Class II | |
| K780783 | Autozyme Cholesterol-Oxidase Reagent Kit | J.T. Baker Chemical Co. | CHH | Class I | |
| K780764 | Non-Sterile Folded Gauze | The Owenby Co. | NAB | Class I | |
| K780757 | Kryorack/4 | Streck Laboratories, Inc. | JRR | Class I | |
| K780753 | Las-R Human Ige Test | Hyland Therapeutic Div., Travenol Laboratories | DGC | Class II | |
| K780725 | Centria Cortisol Ria | Union Carbide Corp. | CGR | Class II | |
| K780714 | Platelet Control | Bhp Diagnostix, Inc. | JPK | Class II | |
| K780684 | Patient Lift | Orthopedic Equipment Co., Inc. | FSA | Class I | |
| K780672 | 125 I-T4 Ria Reagent | Radioimmunoassay, Inc. | CDX | Class II | |
| K780671 | 125 I-T3 Uptake Reagent | Radioimmunoassay, Inc. | CEE | Class II | |
| K780665 | Recap | Bca Biological Corp. of America | KSF | Class II | |
| K780662 | Supplemental Tygon Pac-Monitoring Lines | Norton Performance Plastics Corp. | FMG | Class II | |
| K780628 | Halogen Exam. Lite #48400 | Welch Allyn Inc | KZF | Class I | |
| K780608 | Ice Bag, Vinyl | Abco Dealers, Inc. | KYR | Class I | |
| K780598 | Trend II Aneroid | Abco Dealers, Inc. | DXN | Class II | |
| K780594 | Velket Tourniquet | Abco Dealers, Inc. | GAX | Class I | |
| K780593 | Probe Cover | Abco Dealers, Inc. | FLL | Class II | |
| K780559 | Disposable Infusion Set | Ks Medical Supply Co. | FPA | Class II | |
| K780554 | Clin. Chem. Control Serum-Quantitate | Beckman Instruments, Inc. | JJT | Class I | |
| K780855 | Gamma Camera | G.D. Searle and Co. | IYX | Class I | |
| K780834 | Previ Dent Prophylaxis Mint Ndc | Hoyt Laboratories | EJR | Class I | |
| K780807 | Hbf-Quiplate Methodology | Helena Laboratories, Corp. | JBD | Class II | |
| K780769 | S-100 CT Scanner | Syntex Corp. | JAK | Class II | |
| K780737 | CT Blankets (Bolus Material) | Emi Medical, Inc. | JAK | Class II | |
| K780736 | CT 5221 Dose Reducing Collimators | Emi Medical, Inc. | IZX | Class II | |
| K780724 | Bubble Suction Tubing | Davol, Inc. | BYY | Class II | |
| K780613 | Enema, Phosphate | Abco Dealers, Inc. | FCE | Class I | |
| K780537 | Ear Electrode-Adult & Pediatric | Life-Tech Instruments, Inc. | GXY | Class II | |
| K780471 | Gastric Lavage Kit | Gaymar Industries, Inc. | FAT | Class II | |
| K780465 | Volume Control Device Vcd-150 | Sorensen Research | KZD | Class I | |
| K780828 | Nurite II | Bio-Medical Systems Corp. | GZJ | Class II | |
| K780822 | Hearing Aid Model 8160U | Int'L Hearing Aids, Inc. | ESD | Class I | |
| K780821 | Hearing Aid Model 8160H | Int'L Hearing Aids, Inc. | ESD | Class I | |
| K780820 | Hearing Aid Model 8148 | Int'L Hearing Aids, Inc. | ESD | Class I | |
| K780778 | Rtv Silicone Hand Kneadable Putty | Crown Delta Corp. | ELW | Class II | |
| K780648 | Modified Untreated Tampax Tampons | Tampax, Inc. | HEB | Class II | |
| K780630 | Controller, Servo, Inspiron | C.R. Bard Inc | BZE | Class II |