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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K190081 | RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector | STERIS Corporation | NVE | Class II | |
| K190044 | VSP Orthopedics System | 3D Systems, Inc. | PBF | Class II | |
| K190026 | Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) | Teleflex Medical | BSP | Class II | |
| K183390 | QNext and DG-PT | Diagnostic Grifols, S.A. | JPA | Class II | |
| K191936 | iNSitu Total Hip System | Thecken Companies, LLC | LPH | Class II | |
| K191561 | Exactech Equinoxe Humeral Augmented Trays | Exactech, Inc. | PHX | Class II | |
| K182086 | Arco Fp | A.T.S. Applicazione Tecnologie Speciali S.r.l. | OWB | Class II | |
| K191985 | Optilite IgA Kit | The Binding Site Group Ltd. | CFN | Class II | |
| K191342 | CrossRoads Screw System | Crossroads Extemity Systems, LLC | HWC | Class II | |
| K191339 | Zavation eZspand Interbody System | Zavation Medical Products, LLC | MAX | Class II | |
| K190207 | Blood Pressure Monitor | Shenzhen Viatom Technology Co., Ltd. | DXN | Class II | |
| K183356 | Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch | Weihai Xingtai Packaging Products Co., Ltd. | FRG | Class II | |
| K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device | Titan Spine, LLC | ODP | Class II | |
| K191933 | COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal | Advanced Medical Optics, Inc. | HQC | Class II | |
| K191924 | SAFECARE® THC Urine Strip Test | Safecare Biotech(hangzhou)co.,Ltd | NFW | Class II | |
| K191899 | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions | Roche Diagnostics GmbH | CFR | Class II | |
| K191645 | Skr 4000 | Konica Minolta, Inc. | MQB | Class II | |
| K191636 | APTUS Foot System | Medartis AG | JDR | Class II | |
| K191626 | Stat Profile Prime ES Comp Plus Analyzer System | Nova Biomedical Corporation | JFP | Class II | |
| K191609 | Tria Soft Ureteral Stent | Boston Scientific Corporation | FAD | Class II | |
| K191504 | PowerDR | Radiology Information Systems, Inc. | JAA | Class II | |
| K191349 | 980nm Diode Laser Therapy Device | Shanghai Apolo Medical Technology Co.,Ltd. | GEX | Class II | |
| K191079 | Piezon Built-in Kit, Piezon Built-in Kit LED | E.M.S. - Electro Medical Systems SA | ELC | Class II | |
| K190988 | GIM-STIM OTC TENS/EMS System | Gemore Technology Co., Ltd. | NUH | Class II | |
| K190853 | Vyntus BODY | Jaeger Medical GmbH | BZC | Class II | |
| K190735 | EQ Balance | Upright Science, Inc. | LXV | Unclassified | |
| K190722 | TriMAX Implant System | Crossroads Extemity Systems, LLC | JDR | Class II | |
| K183536 | Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove | Hartalega NGC Sdn Bhd | KGO | Class I | |
| K183108 | Combined Aerobika OPEP and VersaPAP device | Trudell Medical International | BWF | Class II | |
| K191922 | ACUSON P200 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K191916 | Stryker CMF MEDPOR Priority Customized Implant Kit | Stryker Leibinger GmbH & Co. KG | FWP | Class II | |
| K191621 | ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System | Choice Spine LLC | ODP | Class II | |
| K191200 | TULSA-PRO System | Profound Medical Inc. | PLP | Class II | |
| K190991 | Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | MBH | Class II | |
| K190925 | HeartFlow FFRct Analysis | Heartflow, Inc. | PJA | Class II | |
| K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | Sterilmed Inc | NLQ | Unclassified | |
| K190328 | HCT Empty EVA Container Pack | Health Care Technologies | KPE | Class II | |
| K190264 | Viola | Meditime Co., Ltd | NEW | Class II | |
| K183282 | Biovitals Analytics Engine | Biofourmis Singapore Pte., Ltd. | PLB | Class II | |
| K183230 | OneDraw A1C Test System | Drawbridge Health, Inc. | LCP | Class II | |
| K183208 | Suprasorb A + Ag “R” | Speciality Fibres and Materials Limited | FRO | Unclassified | |
| K191553 | NuVaisve® Reline® Cervical System | Nu Vasive, Incorporated | NKG | Class II | |
| K191241 | AutoStrut | Orthospin | KTT | Class II | |
| K190852 | Zurich Pressure Guidewire System Model 100 | Zurich Medical Inc | DXO | Class II | |
| K190849 | IS-III active System_S-narrow Type | Neobiotech Co., Ltd. | DZE | Class II | |
| K190689 | SignalMark Breast Marker | View Point Medical, Inc. | NEU | Class II | |
| K190261 | BOSS Toe Fixation System | Arthrosurface, Inc. | KWD | Class II | |
| K190063 | Servator C SALF Solution | S.A.L.F. SpA | MSB | Class II | |
| K182618 | SleepImage System | Mycardio, LLC dba Sleepimage. | MNR | Class II | |
| K191731 | Instylla Microcatheter | Instylla, Inc. | KRA | Class II |