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 |
|---|---|---|---|---|---|
| K872888 | Ciba Corning 288 Ph/blood Gas System | Ciba Corning Diagnostics Corp. | JQY | Class I | |
| K872838 | Norfolk Norport (Tm) -Sp (Skin Parallel) | Norfolk Medical Products, Inc. | LJT | Class II | |
| K872630 | Endocoagulator(tm) Model 20 Argon Laser for Urolo. | Hgm, Inc. | LNK | Class II | |
| K872566 | Multiple Needle, Injection, Disposable | Cotran Corp. | FMI | Class II | |
| K872446 | Modified Instafil | Instafil, Inc. | LHI | Class II | |
| K872131 | Tandemr M-Pak Lh Immunoenzymetric Assay | Hybritech, Inc. | CEP | Class I | |
| K872097 | Infant Feeding Tube | Centurion Medical Products, LP | KNT | Class II | |
| K872096 | Infant Feeding Kit/set Nasogastric Feeding Kit | Centurion Medical Products, LP | KNT | Class II | |
| K872074 | 5 Mhz Transducer | Sonicaid, Inc. | JOP | Class II | |
| K871999 | Mmg Uro-Self Catheter | Medical Marketing Group | GBM | Class II | |
| K871978 | Codman Flexible Endoscope | Cerenovus, Inc. | GCQ | Class II | |
| K871499 | Protofluor Z | Helena Laboratories, Corp. | JKJ | Class I | |
| K871246 | Ifa Test for Antibodies to Borrelia Burgdorferi | Zeus Scientific LLC | LSR | Class II | |
| K864811 | Rota-Stat | Intl. Diagnostic Laboratories, Ltd. | LIQ | Class I | |
| K873137 | In Vitro 2.5X Roller Bottle | In Vitro Scientific Products | KJC | Class I | |
| K873086 | Round 1 | Bioclinical Systems, Inc. | JXA | Class I | |
| K873062 | Tryptic Soy Agar Pour Tube - Product #T9172 | Lakewood Biochemical Co., Inc. | JSG | Class I | |
| K873061 | Tryptic Soy Agar W/5% Sheep Blood - #T1405 | Lakewood Biochemical Co., Inc. | KZI | Class I | |
| K873060 | Tryptic Soy Agar W/5% Sheep Blood - Product P1002 | Lakewood Biochemical Co., Inc. | KZI | Class I | |
| K873059 | Tryptic Soy Agar (Tsa) Slant - Product #T8765 11Ml | Lakewood Biochemical Co., Inc. | JSG | Class I | |
| K873058 | Tryptic Soy Agar (Tsa) W/5% Horse Blood #P2810 | Lakewood Biochemical Co., Inc. | KZI | Class I | |
| K873057 | Tryptic Soy Agar (Tsa) Slant - Product #T8903 7Ml | Lakewood Biochemical Co., Inc. | JSG | Class I | |
| K873056 | Tryptic Soy Agar (Tsa) W/sxt - Product #P2933 | Lakewood Biochemical Co., Inc. | JSJ | Class I | |
| K873055 | Macconkey Agar - Product #P1606 | Lakewood Biochemical Co., Inc. | JSI | Class I | |
| K873053 | Tryptic Soy Agar (Tsa - Product #P2802) | Lakewood Biochemical Co., Inc. | JSG | Class I | |
| K872776 | Profile Femoral Hip Prosthesis W/porocoat | Depuy, Inc. | KWL | Class II | |
| K872510 | Den-Mat Tenure | Den-Mat Corp. | EBF | Class II | |
| K872493 | Directigen 1-2-3(Tm) Group a Strep Test | BD Becton Dickinson Vacutainer Systems Preanalytic | GTZ | Class I | |
| K872133 | Oxygenator Model No. Bentley 5 Plus | American Bentley | DTZ | Class II | |
| K872071 | Chromotitre E.i.a. Rubella Igg | Ismunit Istituto Immunologico Intaliano | LFX | Class II | |
| K871773 | Bio-Oss Pure Nat Hydroxyapatite Endoss Implant | Geistlich Pharma AG | LYC | Class II | |
| K873107 | Instant Hematoxylin | Shandon, Inc. | HYK | Class I | |
| K873085 | Waymouth 752/1 Medium (Modified) No. 200-2085 | J R Scientific | KIT | Class I | |
| K873084 | Rpmi-1640 Medium (Hat Modified) No. 200-2080 | J R Scientific | KIT | Class I | |
| K872989 | Micrins Needle Holder | Micrins Surgical, Inc. | HXK | Class I | |
| K872955 | Delfia(tm) Ferritin Kit | Lkb Instruments, Inc. | JMG | Class II | |
| K872947 | Porex Quality Plastic Surgery Instruments | Porex Medical | KDG | Class I | |
| K872930 | Biotrol Cholesterol Enzymatique Color | Biotrol, USA, Inc. | CHH | Class I | |
| K872900 | The Portable Orderly | Edgewater Medical Equipment Systems | FWZ | Class I | |
| K872563 | Innotron Innofluor Pheytoin Reagent Set | Innotron of Oregon, Inc. | LGR | Class II | |
| K872513 | Easy-Test Total Bilirubin (Tbil) Item No. 16604 | Em Diagnostic Systems, Inc. | CIG | Class II | |
| K872512 | Emds Total Bilirubin (Tbil) Testpacks, #67675/95 | Em Diagnostic Systems, Inc. | CIG | Class II | |
| K872487 | Vision(r) Total Bilirubin | Abbott Medical | CIG | Class II | |
| K872479 | Asserachrom Protein S Test Kit | American Bioproducts Co. | GGP | Class II | |
| K872451 | Bile Acids Calibrator | Sigma Diagnostics, Inc. | JIT | Class II | |
| K872447 | Cedia(tm) T Uptake | Microgenics Corporation | KHQ | Class II | |
| K872430 | ISO-Data 500 Series Gamma Counter | Iso-Data, Inc. | JJJ | Class I | |
| K872429 | ISO-Data 100 Series Gamma Counter | Iso-Data, Inc. | JJJ | Class I | |
| K872220 | Acs Hi-Torque Flex-T Guide Wire (Modification) | Advanced Cardiovascular Systems, Inc. | DQX | Class II | |
| K872219 | Gen-Probe (R) Luminometer - Leader (Tm) | Hologic, Inc. | JJQ | Class I |