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 |
|---|---|---|---|---|---|
| K900729 | Neoserv 824 | Burdick Corp. | MCJ | ||
| K900260 | Ambu Life Key and Ambu Res-Cue Key | Ambu, Inc. | BTM | Class II | |
| K902345 | Carrington Wound Dressing | Carrington Laboratories, Inc. | FRO | Unclassified | |
| K902282 | Ultra.spec Non-Sterile Latex Examination Glove | Ncl Corp. | LYY | Class I | |
| K902049 | Croak Ovarian Biopsy Forcep | Gynescope Corp. | HFB | Class I | |
| K902019 | Modified Metal Speculum & Special Bullet Forceps | Gynescope Corp. | HDF | Class I | |
| K901411 | Chemoplus Glove | Biosafety Systems, Inc. | LYY | Class I | |
| K900679 | Mint Scented Condoms | Schmid Laboratories, Inc. | HIS | Class II | |
| K891007 | Nonimplanted Electrical Continence Device | Tridak Division of Indicon, Inc. | KPI | Class II | |
| K761234 | Behring Laser Nephelometer | Behring Diagnostics, Inc. | JZW | Class I | |
| K902266 | Electrolyte Controls (Assayed and Unassayed) | Phoenix Diagnostics, Inc. | JJR | Class I | |
| K902123 | Systemate(tm) Direct Bilirubin Catalog No. 65406 | Em Diagnostic Systems, Inc. | CIG | Class II | |
| K901997 | X-Ray Tube Housing Assembly, Various Models | Comet Ltd. C/O Radiology Resources, Inc. | IZH | Class II | |
| K901985 | Blood Gas Controls | Phoenix Diagnostics, Inc. | JJS | Class I | |
| K901938 | Super Strength Denture Adhesive Cream | Teledyne Getz | KOB | Class II | |
| K901805 | Rep(r) Immunofix | Helena Laboratories, Corp. | DAH | Class II | |
| K901796 | Podoflex Exerciser-Passive-Foot/ankle | Component Equipment Mfg., Inc. | ISA | Class I | |
| K901573 | Emit D.a.u. Low and Medium Calibrators B | Syva Co. | DKB | Class II | |
| K901362 | Accessory Fitment to Nebulizer System, Sterile | Automatic Liquid Packaging, Inc. | CAF | Class II | |
| K901302 | Bipolard Polypectomy System (Tm) | Medical Devices Inc. | GEI | Class II | |
| K901236 | Rubber, Dental Dam (Non-Sterile) | Naturub Sdn. Bhd. | EIE | Class I | |
| K901203 | Hypodermic Syringe Luer Lok | Ware-Medics Glass Works, Inc. | FMF | Class II | |
| K901109 | Wound Treatment Kit | Orion Life Systems, Inc. | FRO | Unclassified | |
| K900421 | Promise Absorbent Protective Pad | Scott Health Care | HHD | Class I | |
| K896987 | Rubber Condom (Non-Colored) | Hankook Latex Gongup Co., Ltd. | HIS | Class II | |
| K896630 | Sinovent Maxillary Sinus Drainage System | Atos Medical AB | KAM | Class I | |
| K896142 | Rubber Contraceptive (Condom) | Guangzhou No. 11 Rubber Factory | HIS | Class II | |
| K901429 | Soft, Spring Tipped Nylon Coated Guide Wire | TeleMed Systems | OCY | Class II | |
| K901369 | Green Label Biobrane II and Red Label Biobrane II | Sterling Drug, Inc. | KGN | Unclassified | |
| K901303 | Horizon Surgical Ligating and Marking Clip | Horizon Surgical, Inc. | DSS | Class II | |
| K901273 | L.m.s. Self-Detachable Broach with Stop | Med-Tek Corp. | HTY | Class II | |
| K901204 | Expanded Marketing of Models Ir104 & Ir205 Lasers | Niic U.S.A., Inc. | GEX | Class II | |
| K901128 | Lasercomp Model Star 10 for Oral,gynecology Surg. | Lasercomp | GEX | Class II | |
| K900430 | Irrigation and Suction Apparatus | Acorn Group, Inc. | JCX | Class II | |
| K896850 | Lima Ceramic Femoral Head Biolox by Feldmuehle | Lima Intl. Corp. | LZO | Class II | |
| K896648 | Concept Unicompartmental Knee System | Concept, Inc. | HSX | Class II | |
| K901416 | Condom (Rubber) Contraceptive | Aladan Corp. | HIS | Class II | |
| K902182 | Modified Sterile Latex Examination Gloves | Aladan Corp. | LYY | Class I | |
| K902181 | Modified Non-Sterile Latex Examination Gloves | Aladan Corp. | LYY | Class I | |
| K902154 | Na Latex Myoglobin Test | Behring Diagnostics, Inc. | DDR | Class II | |
| K902037 | Pathodx Pyr Kit | Siemens Healthcare Diagnostics Inc. | JTO | Class I | |
| K901996 | Filtertek Pn 60650 Dialysis Transducer Protector | Filtertek, Inc. | FIB | Class II | |
| K901973 | Cp-3 Dental Polishing Material | Gresco Products, Inc. | EJR | Class I | |
| K901911 | Vivaalloy Hr (Amalgam) | Ivoclar North America, Inc. | EJJ | Class II | |
| K901844 | Uresil Tru-Close Drainage Bag | Uresil, LLC | EXF | Class II | |
| K901753 | 600 or 1200 Ml. Enteral Bag Administration Set | Chartermed, Inc. | KNT | Class II | |
| K901694 | Spec(tm) Extraction Cartridge | Toxi-Lab, Inc. | DKE | Class II | |
| K901214 | Rigid Ureteroscope | Applied Urology, Inc. | FGB | Class II | |
| K901130 | Entera-Flo Feeding Tube | Fresenius Pharma | KNT | Class II | |
| K901084 | Isoflo Intrauterine Pressure Monitoring & Amnio. | Healthdyne Cardiovascular, Inc. | KXO | Class II |