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 |
|---|---|---|---|---|---|
| K250452 | CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B) | Macrolux Medical Technology Co., Ltd. | FED | Class II | |
| K250410 | GORE® Tri-Lobe Balloon Catheter | W. L. Gore & Associates, Inc. | DQY | Class II | |
| K251376 | LimFlow ARC | LimFlow Inc. | PDU | Class II | |
| K251406 | BriefCase-Triage | Aidoc Medical Ltd. | QAS | Class II | |
| K251383 | Prestige Coil System (Prestige Packing Line Extension) | Balt USA, LLC | KRD | Class II | |
| K251238 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010) | Maquet Cardiovascular LLC | GEI | Class II | |
| K251063 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | QUW | Class II | |
| K250957 | Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D) | Olympus Medical Systems Corp. | EOQ | Class II | |
| K250637 | VCFix Spinal System | Amber Implants BV | NDN | Class II | |
| K250581 | KALA Red Light Face Mask (KALA-01) | Shenzhen Kaiyan Medical Equipment Co., Ltd | OHS | Class II | |
| K250368 | Wearable Breast Pump (Model S21) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K250365 | Motif Aura Glow breast pump (Model Motif Aura Glow) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K250317 | EsFlow PLUS | Spident Co., Ltd. | EBF | Class II | |
| K250236 | Swoop® Portable MR Imaging® System (V2) | Hyperfine, Inc | LNH | Class II | |
| K250195 | MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) | Matelaser, Inc. | GEX | Class II | |
| K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) | Corcym Inc. | DTR | Class II | |
| K250078 | Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) | Mindset Medical, Inc. | QME | Class II | |
| K250024 | TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K243863 | Opulus™ Lymphoma Precision | Roche Molecular Systems Inc | QIH | Class II | |
| K243654 | DentalJect | Vapocoolshot, Inc | MLY | Unclassified | |
| K243530 | Dynamic TiBase | Talladium Espana, SL | NHA | Class II | |
| K243522 | ViVi® Toga Premium | Thi Total Healthcare Innovation GmbH | FYA | Class II | |
| K243505 | 5008X Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | |
| K243010 | Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce | Owens & Minor (O&M) Halyard, Inc. | FXX | Class II | |
| K243005 | AudaxCeph Cephalogram Analysis Software | Audax d.o.o. | QIH | Class II | |
| K242926 | XBody Go USA, XBody Pro USA | Xbody Hungary Kft. | NGX | Class II | |
| K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. | POV | Class II | |
| K242751 | ARIX Pectus Bar System | Jeil Medical Corporation | HRS | Class II | |
| K242725 | Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | HGX | Class II | |
| K242640 | FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin | Fertipro N.V. | MQL | Class II | |
| K242635 | Endoscopic Distal Attachment (AF-D series) | Alton Shanghai Medical Instruments Co Ltd | FDS | Class II | |
| K241313 | OHC COVID-19 Antigen Self Test | Osang, LLC | QYT | Class II | |
| DEN240047 | Allix5 | Clairity, Inc. | SEZ | Class II | |
| K251340 | ProSeal™ Bag Spike with Additive Port (423370ST, 423370) | Epic Medical Pte., Ltd. | ONB | Class II | |
| K251325 | VersaCross Connect™ Transseptal Dilator | Baylis Medical Co., Inc. | DRE | Class II | |
| K251315 | Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II | Remex Medical Corp. | OLO | Class II | |
| K250757 | Radius VSM and Accessories | Masimo Corporation | MHX | Class II | |
| K250673 | CERABIEN MiLai | Kuraray Noritake Dental, Inc. | EIH | Class II | |
| K250606 | Dental Barrier and Sleeves | Yueying Medical Instruments (Langfang) Co., Ltd. | PEM | Class II | |
| K250543 | Voluson™ Performance 16; Voluson™ Performance 18 | GE Healthcare | IYN | Class II | |
| K250307 | Visualase V2 MRI-guided Laser Ablation System (9736422) | Medtronic Navigation, Inc | ONO | Class II | |
| K250215 | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand | Cochlear Ltd | LXB | Class II | |
| K250048 | NEUROMARK System (NMK00301) | Neurent Medical Inc. | GEI | Class II | |
| K243856 | TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026) | Shenzhen Astec Technology Co., Ltd. | NUH | Class II | |
| K243497 | Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US | Shanghai AnQing Medical Instrument Co., Ltd | EOQ | Class II | |
| K243484 | PM2+ System and SmartPICC Stylet | Piccolo Medical | LJS | Class II | |
| K243480 | SuturePatch Tissue Reinforcement | Arthrex GmbH | OWX | Class II | |
| K243469 | Signex | Osteonic Co., Ltd. | HRS | Class II | |
| K243372 | BiliWrap | Gerium Medical Ltd | LBI | Class II | |
| K243309 | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | Terumo Europe N.V. | FMI | Class II |