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 |
|---|---|---|---|---|---|
| K954337 | Genotropin Mixer | Pharmacia, Inc. | FMF | Class II | |
| K954336 | Endo-Bend Grasper (114.3 Mm Shaft-Sterile) | Aust & Taylor Medical Corp. | EOB | Class II | |
| K954184 | Jed-Light Fiberoptic Light Source | JEDMED Instrument Company | EQH | Class I | |
| K954149 | Aspect Digital Formatter | Aspect Electronics, Inc. | LMC | Class II | |
| K954040 | Asserachrom Total Protein S Kit | American Bioproducts Co. | GGP | Class II | |
| K954017 | Asserachrom Free Protein S Kit | American Bioproducts Co. | GGP | Class II | |
| K953939 | Quintest | Bayer Corp. | SCL | Class II | |
| K953909 | Scimed 6 French Micro-Max Guide Catheter | Scimed | DQY | Class II | |
| K953894 | Siemens Multileaf Collimator | Siemens Medical Solutions USA, Inc. | IXI | Class II | |
| K953603 | Hearing Today Hearing Aid | Hearing Today Laboratory, Inc. | ESD | Class I | |
| K953499 | Axsym Methadone | Abbott Medical | DJR | Class II | |
| K952292 | Puritan-Bennett Companion Nasal CPAP System | Medtronic, Inc. | BZD | Class II | |
| K951943 | Chrom Z Chromogenic Assays | Helena Laboratories, Corp. | JBQ | Class II | |
| K951830 | Advantage Sim | General Electric Co. | KPQ | Class II | |
| K951262 | Operating Arm System (Oas) | Radionics Software Applications, Inc. | LLZ | Class II | |
| K951081 | Ob/gyn Packs | Sterile Concepts, Inc. | KNA | Class II | |
| K950513 | Archivemanager | Cemax, Inc. | LMD | Class I | |
| K940188 | Paratrend 7 Satellite Intravascular Blood Gas Monitoring System | Biomedical Sensors, Inc. | CCC | Class II | |
| K955094 | Examination Pad | Inventive Products, Inc. | IYO | Class II | |
| K954612 | Abl System 625, 615, 605 | Radiometer America, Inc | CHL | Class II | |
| K954465 | Fms Duo | Future Medical Systems, Inc. | HRX | Class II | |
| K954323 | Mas Liquid Urinalysis Control | Medical Analysis Systems, Inc. | JJY | Class I | |
| K954201 | Buonafede Pneumatic Sleeve | Promedic, Inc. | KCY | Class I | |
| K954175 | Duo Balloon System (Dbs) 1[10 and 12 Mm Sizes] | Origin Medsystems, Inc. | GCJ | Class II | |
| K954174 | Duo Balloon System (Dbs) 2 [10 and 12 Mm Sizes] | Origin Medsystems, Inc. | GCJ | Class II | |
| K953829 | Safe-T-Seal | Gs Medical Packaging, Inc. | KCT | Class II | |
| K953815 | 5 Lpm Oxygen Concentrator | Devilbiss Health Care, Inc. | CAW | Class II | |
| K953730 | Codman Anterior Cervical Plate System | Johnson & Johnson Professionals, Inc. | KWQ | Class II | |
| K953671 | Orgen Tec Anti-Dsdna Elisa Assay | Orgentec | LRM | Class II | |
| K952478 | Boehringer Mannheim Cardiac T Troponin T Rapid Assay | Boehringer Mannheim Corp. | MMI | Class II | |
| K951681 | Quad 1200 Magnetic Resonance Imaging Scanner | Fonar Corp. | LNH | Class II | |
| K951329 | Immuchem Gal-Mw Ea | Icn Pharmaceuticals, Inc. | JIA | Class I | |
| K950986 | Neuroreader | Artronics | HCS | Class II | |
| K946018 | TENS-It, Fittronic II, (More Later) | Ems, Inc. | GZL | Class II | |
| K945476 | Hearthwatch Iii(tm) | Instromedix, Inc. | DXH | Class II | |
| K954802 | Rite-Angle Disposable Prophy Angles | Ash-USA | EGS | Class I | |
| K954295 | Marlene Stockings & Tights | Professional Products, Inc. | DWL | Class II | |
| K954230 | Sorbsan Plus Topical Wound Dressing | Dow Hickam Pharmaceuticals, Inc. | KMF | Class I | |
| K954068 | General Hygiene Kit | Physician Industries, Inc. | KHR | Class I | |
| K954012 | Disposable Prophy Handpiece | Denticator Intl., Inc. | EFB | Class I | |
| K953799 | Dg Examiner Plus | Medelec, Ltd. | OLT | Class II | |
| K953735 | Autoject Mini | Owen Mumford USA, Inc. | KZH | Class II | |
| K953711 | Air Entrainer 900Rt008 | Fisher & Paykel Electronics, Ltd. | BZR | Class II | |
| K953234 | Screw Implants, Grade 3; Uncoated, Ha, Tp-B3 | Implant Center of the Palm Beaches | DZE | Class II | |
| K953196 | Cardio-Systems Pro-Op | Ch Administration, Inc. | FNM | Class II | |
| K950628 | First Choice Test Strip | Polymer Technology Intl. | CGA | Class II | |
| K946374 | Kimono Microthin | Mayer Laboratories | HIS | Class II | |
| K946166 | First Choice(tm) Test Strip | Polymer Technology Intl. | CGA | Class II | |
| K942029 | Arthroscope | Surgical Technologies, Inc. | HRX | Class II | |
| K920633 | Pessary Flexible Silicone Nichols | Bioteque America Inc | KXP | Class II |