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 |
|---|---|---|---|---|---|
| K901926 | Sorba Model Cic-1000 W/new Electrodes | Sorba Medical Systems, Inc. | DXG | Class II | |
| K901884 | 7620 Remote Central Station Repeater | Marquette Electronics, Inc. | DXJ | Class II | |
| K901858 | Modified Labeling for Aca Lipase Analytical Test | E.I. Dupont de Nemours & Co., Inc. | CET | Class I | |
| K901673 | Prolactin (Lactogen) Test System | Baxter Healthcare Corporation | CFT | Class I | |
| K901565 | Atraumax Surgical Clamp Model Fog-5048, 75Mm Side | Applied Vascular Devices, Inc. | DXC | Class II | |
| K901537 | Modified Opus Phenobarbital Test System | Pb Diagnostic Systems, Inc. | LET | Class II | |
| K901510 | Enzymatic Theophylline Reagent, #500-82 | Diagnostic Chemicals, Ltd. (USA) | KLS | Class II | |
| K901480 | F-20 Total Hip Prosthesis | Med-Tek Corp. | JDI | Class II | |
| K901465 | Absorbable Gauze Drape | Ulti-Med Intl., Inc. | KKX | Class II | |
| K901463 | Rep(tm) Spe Plus-16 (Ponceau S) and (Amido) | Helena Laboratories, Corp. | JQJ | Class I | |
| K901402 | Vs-1 Lead Ext. 033-302, 4.75Mm 033-260, 033-458 | Telectronics Pacing Systems, Inc. | DTB | Class III | |
| K901399 | Powerbase II (Pb2) | Nellcor, Inc. | DQA | Class II | |
| K901378 | Tensoplus Lite | Smith & Nephew United, Inc. | NAD | Class I | |
| K900718 | Rotag Fructosamine (Glycated Protein) Assay | Roche Diagnostic Systems, Inc. | LCP | Class II | |
| K900415 | c.p.r. Landmarc | Can-Am Medical, Inc. | LIX | Class II | |
| K900386 | Acs Advanced Concept Guide Wire | Advanced Cardiovascular Systems, Inc. | DQX | Class II | |
| K896467 | Satellite C Blood Cholesterol Monitoring System | Medisense, Inc. | CHH | Class I | |
| K893218 | Ap900/prp Module and Accessories, Modification | Electromedics, Inc. | CAC | Class II | |
| K902466 | Titan Zodiac Adjusting Table | Titan Tables | INW | Class I | |
| K902465 | Titan Hercules Adjusting Table | Titan Tables | INW | Class I | |
| K902452 | Continuous Passive Motion (Cpm) Leg Exerciser | Berner Assoc., Inc. | BXB | Class I | |
| K902440 | Rx Rocker Triumph, Jr. Wheelchair | The RX Rocker Corp. | IOR | Class I | |
| K902060 | Escort Model 300 | Medical Data Electronics | DQA | Class II | |
| K901501 | Corpak Gastrostomy Tube | Corpak Co. | KGC | Class II | |
| K901439 | Disp. Endoscope Cleaning Brush - Squeeky Clean | TeleMed Systems | FEB | Class II | |
| K901339 | Biopsy Forceps (Non-Rigid) | Applied Medical Technologies | KNW | Class II | |
| K901250 | Plexus 2(Tm) Infant Hollow Fiber Oxygenator | Shiley, Inc. | DTZ | Class II | |
| K901249 | Plexus 3.5(Tm) Pediatric Hollow Fiber Oxygenator | Shiley, Inc. | DTZ | Class II | |
| K901224 | Insite Steerable Guidewire | Lake Region Mfg., Inc. | DQX | Class II | |
| K900619 | Caas Unicomparmental Knee System | Techmedica, Inc. | HSX | Class II | |
| K900494 | Synectics Liberty System, Pc Polygraf & Polygram | Synectics-Dantec | FAP | Class II | |
| K900321 | Dynatron 330 Body Composition Analyzer | Dynatronics Laser Corp. | DSB | Class II | |
| K900016 | Trans/r - Fp(3) | CIVCO Medical Instruments Co., Inc. | FCY | Class I | |
| K896714 | Ausonics 5000 | Ausonics Pty, Ltd. | IYO | Class II | |
| K894152 | Meditherm | Medical Equipment Designs, Inc. | IMI | Class II | |
| K902366 | Modified Proxima Monitor/digitrapper Ed Unit | Synectics-Dantec | FFT | Class I | |
| K902195 | Tbd TENS Reusable Electrode | Empi | GXY | Class II | |
| K902074 | Kinamed Cemented Cth Stem | Kinamed Inc | LZO | Class II | |
| K902073 | Kinamed Cemented Ath-Long Stem | Kinamed Inc | LZO | Class II | |
| K901686 | Nidek/phaco Emulsification System Model Cv-8000 | Nidek, Inc. | HQC | Class II | |
| K901513 | Nidek Rt-1200S (Marco Trs-1200) | Nidek, Inc. | HKO | Class I | |
| K901466 | Mesamiv Recorder | Madaus Medtec, Inc. | BZQ | Class II | |
| K901434 | Papillotome | TeleMed Systems | KWS | Class II | |
| K901407 | Core Disposable Trocars | Core Dynamics, Inc. | HET | Class II | |
| K901231 | Rmi Cardioplegia Delivery Kits | Research Medical, Inc. | DWF | Class II | |
| K901133 | Duracath | Impra, Inc. | LFJ | Class II | |
| K901081 | Pro-Lock(tm) Shielding Needle Connector Assembly | VLV Associates, Inc. | FPA | Class II | |
| K901046 | Versa-Lock(tm) Universal Needle Connector | VLV Associates, Inc. | FPA | Class II | |
| K901036 | Non-Prescription Sunglasses | The Bonneau Co. | HQY | Class I | |
| K900770 | Home Urodata System(tm) | Biodan Medical Systems, Ltd. | EXY | Class II |