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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K875323 | Modified Schneider-Shiley Wire Torquer | Schneider-Shilley (USA) | DQX | Class II | |
| K875322 | Modified Schneider-Shiley Pressure Manometer | Schneider-Shilley (USA) | KRK | Class II | |
| K874894 | Tecnol Laser Surgical Mask | Tecnol New Jersey Wound Care, Inc. | FXX | Class II | |
| K881084 | Utility Clamp | Med-Dex Intl. | GDJ | Class I | |
| K881060 | Osi Rizzoli Trauma Table (Electric Version) | Mizuho Orthopedic Systems Inc | JEA | Class I | |
| K881020 | Surgical Sealant Dispenser (Ssd) | Micromedics, Inc. | KYZ | Class I | |
| K880896 | Nova Gel(tm) Ss-A/ss-B | Inova Diagnostics, Inc. | LLL | Class II | |
| K880828 | Wako(tm) Igm-Ha Direct | FUJIFILM Healthcare Americas Corporation | DFT | Class II | |
| K880742 | Nova Lite(tm) Dsdna | Inova Diagnostics, Inc. | DHN | Class II | |
| K880736 | Nova Lite(tm) Ana | Inova Diagnostics, Inc. | LLL | Class II | |
| K880730 | Kallestad Qm2/qm300 Control C Pack | Kallestad Diag, A Div. of Erbamont, Inc. | DCK | Class II | |
| K880728 | Kallestad Qm300 C-Reactive Protein Antibody Pack | Kallestad Diag, A Div. of Erbamont, Inc. | DCN | Class II | |
| K880718 | Calcofluor White Stain Kit | Remel Inc | JTS | Class I | |
| K880547 | Ventrezyme Vast Immuno-Peroxidase Assay | Ventrex Laboratories, Inc. | DHB | Class II | |
| K880414 | Tendon Harvester | Concept, Inc. | HRX | Class II | |
| K880074 | Rsi Glenoid Arcuate Bone Drill W/disp. Flexi-Bits | Romano Surgical Instrumentation, Inc. | HSZ | Class I | |
| K875327 | Modified Seldinger Initial Puncture Instrument | Schneider-Shilley (USA) | DRE | Class II | |
| K875324 | Modified Schneider Shiley Inflation Syringes | Schneider-Shilley (USA) | DXT | Class II | |
| K874136 | Photic Stimulator Models 580-Pscomp,psceeg,psstal | Bio-Logic Systems Corp. | GWE | Class II | |
| K873410 | Disposable Angiographic, Control Syringe | Blood Gas Supply Co. | DXT | Class II | |
| K871934 | Model 5050 Surgilaser for Gastro-Intestinal Use | Lasermatic, Inc. | LNK | Class II | |
| K871932 | Model 5050 Surgilaser for Urology Use | Lasermatic, Inc. | LNK | Class II | |
| K881115 | Bactec(r) Nr26 and Bactec(r) Nr 27 Culture Media | BD Becton Dickinson Vacutainer Systems Preanalytic | JSG | Class I | |
| K881067 | Non Conductive, Single Use Anesthesia Face Mask | Medesign, Inc. | BSJ | Class I | |
| K880999 | Epipack | Clonetics Corp. | KIT | Class I | |
| K880990 | Ats 0.2% Bovine Albumin Fraction V Solution | Alpha-Tec Systems, Inc. | JSY | Class I | |
| K880731 | Wako Autokit Uric Acid | FUJIFILM Healthcare Americas Corporation | KNK | Class I | |
| K880710 | Protein Base Ise Control | Bionostics, Inc. | JJR | Class I | |
| K880701 | Quantimetrix Serum Enzyme Control | Quantimetrix Corp. | JJT | Class I | |
| K880687 | Cortisol Enhanced Luminescence Assay Kit | Amersham Corp. | CGR | Class II | |
| K880677 | Total Protein Reagent Set | Tech-Neal Scientific, Inc. | CEK | Class II | |
| K880676 | Inorganic Phosphorus Reagent Set | Tech-Neal Scientific, Inc. | CEO | Class I | |
| K880651 | Paramax Ammonia Reagent | Baxter Healthcare Corporation | JIF | Class I | |
| K880620 | Emit Thyroxine Assay | Syva Co. | KLI | Class II | |
| K880610 | Unimeter Calibration Kit | Boehringer Mannheim Corp. | JIW | Class II | |
| K880606 | Utility Wax Strips, Cinnamon | Columbus Dental Mfg. Co. | EGD | Class I | |
| K880546 | Total Iron Binding Capacity (Tibc) | Boehringer Mannheim Corp. | JMO | Class I | |
| K880497 | Word Bartholin Gland Catheter Code: 1005 | Hoosier Specialties, Inc. | KNA | Class II | |
| K880467 | Stanbio Cab Total Iron Procedure, Liquicolor | Stanbio Laboratory | JIY | Class I | |
| K880452 | Lumiscope TENS Model 2000T or Apcc 3001 or Pain Re | Lumiscope Co., Inc. | GZJ | Class II | |
| K880313 | Wako(tm) Autokit Albumin | FUJIFILM Healthcare Americas Corporation | CIX | Class II | |
| K880312 | Wako(tm) Autokit Total Protein | FUJIFILM Healthcare Americas Corporation | CEK | Class II | |
| K880296 | Lumatag(tm) Prolactin Chemilumines. Immuno. Assay | London Diagnostics, Inc. | CFT | Class I | |
| K880291 | Theophylline Test Kit Ref. #A874799 | Photec Diagnostics, Inc. | LCA | Class II | |
| K880173 | Model 4900 Nd:yag Laser for Endometrial Ablation | Cooper Lasersonics, Inc. | HHR | Class II | |
| K880170 | Model 4900 Nd:yag Laser for Pulmonary Obstructions | Cooper Lasersonics, Inc. | LLO | Class II | |
| K880070 | Abbott Imx Hcg | Abbott Medical | JHI | Class II | |
| K880043 | Ebv-Na Test | Gull Laboratories, Inc. | LLM | Class I | |
| K880006 | Sta-Set i.v. Flow Regulator | Controlled Flow, Ltd. | LDR | Class II | |
| K875371 | Kontron Sigma 1 Digital Echocardiograph System | Kontron Instruments, Inc. | HGL | Class II |