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 |
|---|---|---|---|---|---|
| K960312 | Rdi Cardiac Insulation Pad | R D Intl. | DWP | Class II | |
| K960294 | Phase Conjugate Symmetry Option for Outlook | Philips North America LLC | LNH | Class II | |
| K960240 | Rusch Optosafe | Rusch Intl. | CAE | Class I | |
| K960139 | G.e. Sterile Angiographic Tray | GE Healthcare | DWS | Class I | |
| K955605 | Relisa Jo-1 Antibody Test System | IMMUNO CONCEPTS, NA, Ltd. | LLL | Class II | |
| K955604 | Relisa Sm/rnp Antibody Test System | IMMUNO CONCEPTS, NA, Ltd. | LLL | Class II | |
| K955603 | Relsia Ss-A/ro & Ss/b La Antibody Test System | IMMUNO CONCEPTS, NA, Ltd. | LLL | Class II | |
| K955602 | Relsia Scl-70 Antibody Test System | IMMUNO CONCEPTS, NA, Ltd. | LLL | Class II | |
| K955450 | Pathromtin Sl | Behring Diagnostics, Inc. | GFO | Class II | |
| K953904 | Sarns 9000 Universal Roller Pump | 3M Company | DWB | Class II | |
| K953901 | Sarns 800 Roller Pump | 3M Health Care, Sarns | DWB | Class II | |
| K961285 | Argedent 40(Gold-Palladium-Silver Alloy for Porcelain Application) | Argen Precious Metals, Inc. | EJT | Class II | |
| K961084 | Am 400 | Electone, Inc. | ESD | Class I | |
| K960996 | M. Cat Butyrate Disk | Hardy Diagnostics | JTO | Class I | |
| K960938 | Prov-Kb | Silicon-Und Composite Spezialitaten GmbH | EBG | Class II | |
| K960626 | Modular Oncology System Technology (Most) | Intermedics Orthopedics | JDI | Class II | |
| K960516 | Fastak Suture Anchor | Arthrex GmbH | MBI | Class II | |
| K960451 | Webb-Morley Spine System | Buckman Co., Inc. | MNH | Class II | |
| K960439 | Lm Bone Anchor | Li Medical Technologies, Inc. | MBI | Class II | |
| K960368 | Osteograft/n-700 Hydroxylaptite | Ceramed Corp. | LYC | Class II | |
| K960353 | Osteograf/ld-300 Hydroxylapatite | Ceramed Corp. | LYC | Class II | |
| K960311 | Perineometer | Hollister, Inc. | HIR | Class II | |
| K955859 | Immunocard Toxin a | Meridian Diagnostics, Inc. | LLH | Class I | |
| K955717 | Endoscope Introducer Kit | Mitsubishi Cable America, Inc. | FDE | Class II | |
| K954832 | Orgentec Anti-Ss-B(la) Pin Immuno Assay | Orgentec | LJM | Class II | |
| K954829 | Orgentec Anti-Jo-1 Pin Immuno Assay | Orgentec | LJM | Class II | |
| K954815 | Orgentec Anti-Ss-A(ro) Pin Immuno Assay | Orgentec | LJM | Class II | |
| K954814 | Orgentec Anti-Scl 70 Pin Immuno Assay | Orgentec | LJM | Class II | |
| K954549 | Surgical Apparel | Global Healthcare, Inc. | FYC | Class II | |
| K952712 | White River Battery-Powered Breast Pump | Natural Technologies, Inc. | HGX | Class II | |
| K950688 | Omin-Trak Model 3500 Series Patient Monitoring System | Safety Tek Corp. | DRT | Class II | |
| K943104 | Molloy Intubating Stylette | Molloy Corp. | BSR | Class I | |
| K933469 | Univec Non-Reusable Syringe | Univec, Inc. | MEG | Class II | |
| K931336 | Drs 4 Dialyzer Reprocessing System | Seratronics, Inc. | LIF | Class II | |
| K961129 | Arema II | Mellen Air Mfg., Inc. | FNM | Class II | |
| K961119 | Carefree Pantyliners | Personal Products Co. | HHL | Class II | |
| K960921 | Codan Medlon Bc110 Vial Adapter Codan Spike | Codan Medlon, Inc. | LHI | Class II | |
| K960448 | Lm Anchor | Li Medical Technologies, Inc. | MBI | Class II | |
| K960382 | Kodak Digital Science Medical Image Manager | Eastman Kodak Company | LMD | Class I | |
| K960341 | Tampax Tampon with Additive Junior,regular,super, and Super Plus | Tambrands Inc. | HEB | Class II | |
| K960285 | Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug Delivery Systems 0.0058/0.0068(Inch Diameter Nozzleorific | Medi-Ject Corp. | KZE | Class II | |
| K960071 | Imagefusion | Radionics Software Applications, Inc. | LLZ | Class II | |
| K954955 | Storc Intrauterine Pressure Catheter | Clinical Innovations, LLC | HFN | Class II | |
| K953716 | Intracavity Transducers | Biosound, Inc. | ITX | Class II | |
| K953522 | Usci Ideal Ptca Kit | Ryder Intl. Corp. | MAV | Class II | |
| K952797 | At53 Dual Channel EMG | Stoelting Co. | HCC | Class II | |
| K952435 | Celsite Pediatric Venous System | B.Braun Medical, Inc. | LJT | Class II | |
| K944459 | Accu-Chek Instant Plus G-C/dm Blood Glucose Monitoring System | Boehringer Mannheim Corp. | CGA | Class II | |
| K932661 | Whatman Body Fluid Collection Paper:whatman Bfc180 | Whatman Specialty Products, Inc. | PJC | Class II | |
| K961177 | Carolina Narrow Fabric Company Closed Toe Anti-Embolism Stocking | Carolina Narrow Fabric Co. | DWL | Class II |