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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K000128 | Hardydisk, Cefazolin, 30Mcg | Hardy Diagnostics | JTN | Class II | |
| K000070 | Flocath | Rusch Intl. | KOD | Class II | |
| K000055 | Creatinine-S Assay, Model 221-30, 221-50, 221-17 | Sekisui Diagnostics P.E.I. Inc. | CGX | Class II | |
| K994134 | Hardydisk Oxacillin, 1Mcg | Hardy Diagnostics | JTN | Class II | |
| K992556 | Permacol | Tissue Science Laboratories, PLC | FTL | Class II | |
| K991737 | Lilliput Phospholypidic Inert Surface in Oxygenation (Ph.i.s.i.o.) Infant/newborn Hollow Fiber Oxygenator | Dideco S.p.A. | DTZ | Class II | |
| K000119 | Sjm Tailor Annuloplasty Ring, Model Tarn | Abbott Medical | KRH | Class II | |
| K000022 | Hardydisk Cefamandole, 30Mcg | Hardy Diagnostics | JTN | Class II | |
| K994432 | Hwa & Silktex Powdered Latex Examination Gloves, with Protein Content Labeling Claim (140 Micrograms or Less) | Hwa Teh Industrial Sdn. Bhd. | LYY | Class I | |
| K994425 | Modification to Endoscopic Spinal Access System | Endius, Inc. | HRX | Class II | |
| K994314 | Castle Series 100Hc Steam Sterilizers | Getinge/Castle, Inc. | FLE | Class II | |
| K994150 | Hardydisk Norfloxacin, 10Mcg | Hardy Diagnostics | JTN | Class II | |
| K994135 | Hardydisk Erythromycin, 15Mcg | Hardy Diagnostics | JTN | Class II | |
| K994012 | Tempofit, Model 02693 | Detax GmbH & Co. KG | EBG | Class II | |
| K993872 | Vanna Bathing System | Vancare, Inc. | ILJ | Class II | |
| K993846 | Ultraseal Xt Plus | Ultradent Products Inc. | EBC | Class II | |
| K993332 | Gradiplasma La High, Gradiplasma La Low Models Lahp-1, Lahp-05, Lalp-1, Lalp-05 | Gradipore, Ltd. | GGC | Class II | |
| K992751 | Somavision | Varian Assoc., Inc. | KPQ | Class II | |
| K984565 | Tmc-Easy-302 | Tmc Magnetics & Machinery Corp. | INI | Class II | |
| K981936 | Abd Varisoft Steerable Guide Wire and Abd Varisoft Guide Wire Extension | Advanced Biomedical Devices, Inc. | DQX | Class II | |
| K000379 | Modofication to Afffinity 38 Micro Arterial Blood Filter with Carmeda Bioactive Surface, Models Cb351/cb352 | Medtronic, Inc. | DTM | Class II | |
| K000334 | Impact Modular Total Hip System | Zimmer GmbH | LPH | Class II | |
| K000295 | Encore Microptic Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 Micrograms or Less) | Ansell Perry | KGO | Class I | |
| K000242 | Acumatch a-Series Corundum Acetabular Component and Acumatch a-Series Corundum Acetabular Component with Hydroxyapatite | Exactech, Inc. | MEH | Class II | |
| K000236 | Synergy Vls Cap Nut Models 2206, 6102 | Interpore Cross Intl. | MNI | Class II | |
| K000159 | Agfa Diagnostic Center Adc, Adc Compact, and Adc Solo | Agfa Corp. | IXK | Class II | |
| K994212 | Hardydisk Mezlocillin 75Mcg | Hardy Diagnostics | JTN | Class II | |
| K994184 | Plr Splined Revision Stem | Zimmer GmbH | LZO | Class II | |
| K994159 | Hmp Controls (Tas) Rapidpoint | Cardiovascular Diagnostics, Inc. | GGN | Class II | |
| K994154 | Mod Line of Molina Distractors, 51-600 Series | KLS-Martin L.P. | JEY | Class II | |
| K993408 | Remed Male Ribbed Condom Preventor, Lucky Boy Summit | Remed Pharma | HIS | Class II | |
| K993405 | Remed Male Dotted Condom Preventor, Lucky Boy, Summit | Remed Pharma | HIS | Class II | |
| K993404 | Remed Male Latex Condom (Classic) Preventor, Lucky Boy, and Summit | Remed Pharma | HIS | Class II | |
| K993396 | Remed Male Extra Strength Condom Preventor, Lucky Boy, Summit | Remed Pharma | HIS | Class II | |
| K993395 | Remed Male Latex Condom (Double Whooper) Preventor, Lucky Boy and Summit | Remed Pharma | HIS | Class II | |
| K992662 | 8 Additional Assays for the Bayer Advia 1650 Chemistry System | Bayer Corp. | MSJ | Class I | |
| K991396 | Water for Tissue Culture, Models 500 L & 1.5 L | Sage Biopharma | MQL | Class II | |
| K991395 | Quinn's Htf Medium, Quinn's Htf Medium with Hepes, Quinn's Basal XI Htf Medium, Quinn's D3+ Htf Medium | Advanced Reproductive Technologies | MQL | Class II | |
| K000310 | Voyager 6.0 Software Option | Philips North America LLC | HAW | Class II | |
| K000300 | Lightspeed 2.0Ct Scanner System | GE Healthcare | JAK | Class II | |
| K000116 | Qualitrol Urinalysis with Microscopics Control, Levels 1,2 and 3 | Consolidated Technologies, Inc. | JJY | Class I | |
| DEN990008 | Wallac Neonatal Biotinidase Test Kit, Models Nb-1000; Nb-4000 | Wallac Oy | NAK | Class II | |
| K994345 | Magna 5000 Phased Array Ctl Spine Coil | GE Healthcare Coils | MOS | Class II | |
| K994061 | Locon-T Distal Radial Plate | Wrightmedicaltechnologyinc | HRS | Class II | |
| K994054 | Issa Pharos | Vams Tec, d.o.o. | LLZ | Class II | |
| K993995 | Vein Entry Indicator Device (Veid) | Vascular Technologies, Ltd. | FMF | Class II | |
| K993960 | Perma-Doc Phantom | Mick Radio-Nuclear Instruments, Inc. | IYE | Class II | |
| K993959 | Isocentric Beam Checker | Mick Radio-Nuclear Instruments, Inc. | IYE | Class II | |
| K993958 | Idx-60 Intraoral X-Ray | X-Cel X-Ray Corp | MUH | Class II | |
| K993903 | Whiteside Biomechanics Titanium Low-Profile Cable, Model Bio-1-1013 | Whiteside Biomechanics, Inc. | JDQ | Class II |