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 |
|---|---|---|---|---|---|
| K942730 | Aesculap Laparoscopes | Aesculap Inc | HET | Class II | |
| K941965 | Ez-Range | Hematronix, Inc. | JPK | Class II | |
| K941188 | Clarus Neuro Endoscope (Model 2230) | Clarus Medical Systems, Inc. | HRX | Class II | |
| K940144 | Clarus Phoenix Endoscope | Clarus Medical Systems, Inc. | HRX | Class II | |
| K940094 | Colposcopes and Accessories | Leisegang Medical, Inc. | HEX | Class II | |
| K930265 | Hydrogen Spectroscopy Option-Probe #M1040hs/ht | GE Healthcare | LNI | Class II | |
| K951491 | Dale Tracheostomy Tube Holder with Trach Mask Attachment Tabs | Dale Medical Products, Inc. | CBH | Class I | |
| K951484 | Westmed Bacterial/viral Filter | Westmed Intl. | CAH | Class II | |
| K951475 | Navarre Universal Drainage Catheter | Navarre Biomedical, Ltd. | GBX | Class I | |
| K951410 | Disposable Pulmonary Function Filter | Creative Biomedics, Inc. | CAH | Class II | |
| K951269 | Disposable & Reusable Monopolar Handswithc Pencil | Boston Surgical Products, Inc. | GEI | Class II | |
| K951101 | Leuko-Test | Techlab, Inc. | DEG | Class I | |
| K950217 | Orgentec Thyroglobulin Pia (Pin Immuno Assay) | American Laboratory Products Company | JZO | Class II | |
| K946318 | Model 1001, Hydrodot(tm) Neuromonitoring System with E Net(tm) EEG Interface Cable | Physiometrix, Inc. | GXY | Class II | |
| K946107 | Gore-Tex Mycromesh Plus Biomaterial | W. L. Gore & Associates, Inc. | FTL | Class II | |
| K946106 | Gore-Tex Dualmesh Plus Biomaterial | W. L. Gore & Associates, Inc. | FTL | Class II | |
| K945883 | Lyfo(tm) Differential Disk-Bile Esculin | Microbiologics, Inc. | JTO | Class I | |
| K945882 | Lyfo(tm) Differential Disk-Bile | Microbiologics, Inc. | JTO | Class I | |
| K945881 | Lyfo(tm) Differential Disk-Sterile Disk | Microbiologics, Inc. | JTO | Class I | |
| K945880 | Lyfo(tm) Differential Disk-Sps | Microbiologics, Inc. | JTO | Class I | |
| K943436 | Urine Reagent Strips-8 Parameters | Teco Diagnostics | JJB | Class I | |
| K951598 | Pro-B Biopsy Needle | Promedical, Ltd. | FCG | Class II | |
| K951178 | Urological Catheter & Accessories | DeRoyal Industries, Inc. | FCM | Class II | |
| K951153 | Cedia Dau Ppx/meth Calibrator | Microgenics Corporation | DLJ | Class II | |
| K950090 | Orgentec Anti-Tpo Pia (Pin Immuno Assay) | American Laboratory Products Company | JZO | Class II | |
| K950089 | Orgentec Anti-Tg Pia (Pin Immuno Assay) | American Laboratory Products Company | JZO | Class II | |
| K950088 | Orgentec Anti-Tg/anti-Tpo Pia (Pin Immuno Assay) | American Laboratory Products Company | JZO | Class II | |
| K945758 | Hi-Tip High Temperature Replacement Tip | Apyx Medical Corporation | GEI | Class II | |
| K945551 | Celsite(tm) Dual Venous System | B. Braun of America, Inc. | LJT | Class II | |
| K944611 | Model# 7500 Surveyor | Devilbiss Health Care, Inc. | MNR | Class II | |
| K943695 | Suretemp | Advanced Bioresearch Assoc. | FLL | Class II | |
| K942376 | Cobas Core Free T3 Eia | Roche Diagnostic Systems, Inc. | CEC | Class II | |
| K940382 | Lysol I.c. Brand Disinfectant | National Laboratories | LRJ | Class I | |
| K925056 | Safesharpe (Tm) Disposal System | Life Medical Technologies, Inc. | FMI | Class II | |
| K951293 | Quantitate Enzyme Verifier Set | Beckman Instruments, Inc. | JJT | Class I | |
| K951235 | Giroc | Health-Dent Intl., Inc. | DYH | Class II | |
| K951176 | Koordinat M | Siemens Medical Solutions USA, Inc. | IXR | Class II | |
| K951170 | Vigil Multichek Controls | Beckman Instruments, Inc. | JJY | Class I | |
| K951136 | Bionike A/q Pregnancy Test | Charlton Assoc. | JHI | Class II | |
| K951057 | Mas Liquid Assayed Alcohol/ammonia Control Level 1 and 2 | Medical Analysis Systems, Inc. | DCK | Class II | |
| K950936 | Bone Cutting Instrument and Accessories | Steri-Oss, Inc. | DZE | Class II | |
| K950857 | Foramatron IV | Parkell, Inc. | LQY | Unclassified | |
| K950353 | Technicon Immuno 1(R) System in-Vitro Diagnostic System | Miles, Inc. | JJE | Class I | |
| K945875 | Mrt-50 Qd Body Coil | Toshiba America Mri, Inc. | LNH | Class II | |
| K945271 | Atac 8000 Random Access Chemistry System | Bio-Chem Laboratory Systems, Inc. | JJE | Class I | |
| K944903 | Hp-Fast | Gi Supply | LYR | Class I | |
| K941262 | Marquette Defib Electrode | Marquette Electronics, Inc. | MKJ | Class III | |
| K931192 | Dako Rabbit Anti-Cow S-100 Polyclonal Antibody | Dako Corp. | DEH | Class II | |
| K950867 | Medi - Pump | Thomas Industries | CAF | Class II | |
| K950615 | Kaplan-Simpson Infusasleeve Catheter | Localmed, Inc. | QEY | Class II |