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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K242356 | TIDAL Fusion Cage System | restor3d, Inc. | SAI | Class II | |
| K241921 | Alinity m BKV | Abbott Molecular, Inc. | QMI | Class II | |
| K250561 | Natural Cycles | Natural Cycles Nordic AB | PYT | Class II | |
| K250556 | Porous Biologic Scaffold | Ventris Medical | MQV | Class II | |
| K250517 | Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator™ HD Ureteral Access Sheath Set 13/15 F x 28cm (M006 | Boston Scientific Corporation | FED | Class II | |
| K250513 | IntelliSep Test (CV-ICG-048) | Cytovale, Inc. | QUT | Class II | |
| K250403 | Catamaran SI Joint Fusion System | Tenon Medical, Inc. | OUR | Class II | |
| K250186 | GoLIF! Lumbar Interbody Fusion System | Getset Surgical S.A. | MAX | Class II | |
| K250106 | Signos Glucose Monitoring System | Signos, Inc. | SAF | Class II | |
| K243980 | ARVIS Surgical Navigation System | Kico Knee Innovation Company | SBF | Class II | |
| K243958 | Consolidated Operating Room Equipment (CORE) 2 Console | Stryker Corp. | OLO | Class II | |
| K243808 | Rayvolve PTX-PE | AZmed | QFM | Class II | |
| K243649 | BD Vacutainer® Multiple Sample Luer Adapter | Becton Dickinson & Co | JKA | Class II | |
| K243630 | Medical Laser System Incanto / Evoline Platinum /Evoline | Solar LS Cjsc | GEX | Class II | |
| K243451 | FiAPC plus probes | ERBE Elektromedizin GmbH | GEI | Class II | |
| K243185 | REMI Remote EEG Monitoring System | Epitel | OMC | Class II | |
| K243032 | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | FFK | Class II | |
| K242909 | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | Edwards Lifesciences LLC | DRS | Class II | |
| K242888 | Electrohydraulic Lithotriptor (TCS-B3-II) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | FFK | Class II | |
| K242564 | Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit) | Prismatik Dentalcraft, Inc. | KCT | Class II | |
| K242289 | Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter | Stryker Corp. | QJP | Class II | |
| K242107 | CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) | Casebioscience, Inc. | MQL | Class II | |
| K242053 | FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | |
| K241890 | Philips Holter Analysis System | Philips Medizin Systeme Boblingen GmbH | MLO | Class II | |
| K241833 | V-Grad | VITROMED GmbH | MQL | Class II | |
| K241065 | ChecQ (AC100) | Dentis Co.,Ltd | EKX | Class I | |
| K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060) | Yukon Medical, LLC | LHI | Class II | |
| K250468 | iSLEEVE Introducer Set | Boston Scientific Corporation | DYB | Class II | |
| K250463 | Ameda GLO Wearable Breast Pump (Model W8S) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K243988 | RootMend MRR | Riverpoint Medical, LLC | MBI | Class II | |
| K243975 | Knee+ | Pixee Medical | SBF | Class II | |
| K243928 | ViaOne Epicardial Access System | CARDIOVIA Ltd. | DYB | Class II | |
| K243922 | Revogene | Meridian Bioscience Inc | OOI | Class II | |
| K243292 | brAIn™ Shoulder Positioning | Avatar Medical | LLZ | Class II | |
| K243016 | Starlight Imaging Catheter | Spectrawave, Inc. | NQQ | Class II | |
| K242958 | Joylux Intimacy Gel (PG3100) | Joylux, Inc. | NUC | Class II | |
| K242771 | Tesera-k PL System and Tesera-k XL System | Kyocera Medical Technologies, Inc. | MAX | Class II | |
| K242770 | Expd 114; Expd 114G; Expd 114P; Expd 114Pg | DRTECH Corporation | MQB | Class II | |
| K241961 | Vent Creativity Knee v1.0 (Hermes) | Vent Creativity | QIH | Class II | |
| K241884 | HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) | Hunan Haipuming Technology Co.,Ltd. | LPL | Class II | |
| K241704 | Endoscopic Water Pump | Hangzhou AGS MedTech Co., Ltd. | OCX | Class II | |
| K250502 | SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000) | Safesource Direct | LZA | Class I | |
| K250429 | DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set | Macromedics BV | IYE | Class II | |
| K250210 | Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D)) | Scivita Medical Technology Co., Ltd. | EOQ | Class II | |
| K250171 | IPL Hair Removal Device (BE965A, BE965B, BE965C) | Shenzhen Yang WO Electronic Co., Ltd | OHT | Class II | |
| K250131 | IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023) | Mustech Electronics Co., Limited | OHT | Class II | |
| K250042 | PeekMed web | Peek Health, S.A. | QIH | Class II | |
| K243999 | TriMed Ankle Fixation System | Trimed Inc | HRS | Class II | |
| K243987 | TriMed Elbow and Forearm System | Trimed Inc | HRS | Class II | |
| K243689 | Aview | Coreline Soft Co., Ltd. | QIH | Class II |