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 |
|---|---|---|---|---|---|
| K894785 | Surgical Chisel/osteotome | Fdt Precision Machine Co., Inc. | KDG | Class I | |
| K894764 | Or Towel Packs | Advance Medical Designs Inc | KKX | Class II | |
| K894760 | Clothinguard | Barrier Concepts, Inc. | FYE | Class I | |
| K894728 | Dyonics Disposable Arthroscopic Surgical Knife | Dyonics, Inc. | HRX | Class II | |
| K894474 | The Autolet Lite | Ulster Scientific, Inc. | FMK | Class II | |
| K894470 | Stryker Trauma Tray | Stryker Corp. | KYZ | Class I | |
| K894274 | Exusorb Transparent Dressing | Controlled Therapeutics Corp. | KGX | Class I | |
| K894119 | Madegom Ltda. Penrose Drain Tubing | Madegom | GBW | Class I | |
| K893987 | Nidek Model Yc-1200 | Nidek, Inc. | LXS | Class II | |
| K893114 | Latex Examination Gloves | Anro Corp. Sdn Bhd | LYY | Class I | |
| K893104 | Latex Examination Gloves | Chuen Her Industries Co., Ltd. | LYY | Class I | |
| K891817 | Patient Exam Gloves (Mfg. Terang Nusa) | Mulpha Intl. Trading Corp. Bhd. | LYY | Class I | |
| K891816 | Patient Exam Gloves (Mfg. Healthcare Gloves) | Mulpha Intl. Trading Corp. Bhd. | LYY | Class I | |
| K891813 | Patient Exam Gloves (Mfg. Aek Rubber Products) | Mulpha Intl. Trading Corp. Bhd. | LYY | Class I | |
| K891812 | Patient Exam Gloves (Mfg. Getah Gayal) | Mulpha Intl. Trading Corp. Bhd. | LYY | Class I | |
| K891811 | Patient Exam Gloves (Mfg. Palmbase Rubber Mfg.) | Mulpha Intl. Trading Corp. Bhd. | LYY | Class I | |
| K891018 | Latex Patient Examination Glove | U.S. Medical Supply, Inc. | LYY | Class I | |
| K894723 | System 2500 Medical Waterbed | Dermanetics Corp. | IOQ | Class II | |
| K894676 | Sterile Latex Exam Gloves | Superior Healthcare Group, Inc. | LYY | Class I | |
| K894635 | Latex Examination Gloves | Ever-More Latex Products Sdn Bhd | LYY | Class I | |
| K894268 | C.a.b. Ring | Medi-Sharp, Inc. | MAB | Class II | |
| K894185 | Optima Mpt Series III Pacemaker, Unipolar/bipolar | Telectronics Pacing Systems, Inc. | DXY | Class III | |
| K894084 | Target Catheters and Guide Wires for Pediatric Use | Target Therapeutics | DQY | Class II | |
| K893976 | Coat-a-Count (Tm) Fsh Irma | Siemens Healthcare Diagnostics Inc. | CGJ | Class I | |
| K893751 | Amylase Test (Aml) Item Number: 65404 | Em Diagnostic Systems, Inc. | JFJ | Class II | |
| K893741 | Receptal (R) Saf-Gard(tm) Suction Liner | Abbott Medical | GCX | Class II | |
| K893731 | Shields T.c. Laser Lens | Ocular Instruments, Inc. | LQJ | Class II | |
| K893398 | Centralite Backpointer | Diacor, Inc. | IWE | Class I | |
| K893325 | Latex Examination Gloves | Hin Fatt Corp. Sdn Bhd | LYY | Class I | |
| K893046 | Hi Latex Examination Gloves | Hansa Intl., Inc. | LYY | Class I | |
| K892974 | Patient Examination Gloves | Dubo Latex, Ltd. | LYY | Class I | |
| K892735 | Ifa Sensibac Cephalotin | Investigacion Farmaceutica S.A. de C.V. | JTN | Class II | |
| K892733 | Ifa Sensibac Kanamycin | Investigacion Farmaceutica S.A. de C.V. | JTN | Class II | |
| K892713 | Ifa Sensibac Nalidixic Acid | Investigacion Farmaceutica S.A. de C.V. | JTN | Class II | |
| K892268 | Patient Examination Gloves (Latex) | Jinnwah Ent., Inc. | LYY | Class I | |
| K890917 | Phoenix Drapes with Microban | Phoenix Medical Technology, Inc. | KGX | Class I | |
| K890405 | Usci Pta Balloon Dilatation Catheter | C.R. Bard Inc | LIT | Class II | |
| K890404 | Usci Probe Linx Extension Wire | C.R. Bard Inc | DQX | Class II | |
| K890152 | Usci Probing Catheter | C.R. Bard Inc | DQY | Class II | |
| K883645 | Lifecare Micro Pump | Abbott Medical | FRN | Class II | |
| K894625 | Chlamydia (Lgv-1) | Bion Ent., Ltd. | LKI | Class I | |
| K894586 | Dale i.v. Identifier; Product #1125 | Dale Medical Products, Inc. | KMK | Class I | |
| K894465 | Abuscreen Radioimmunoassay for Methamphetamine | Roche Diagnostic Systems, Inc. | DKZ | Class II | |
| K894455 | Decontaminating Kit, Skin: M291 | Dept. of the Army | MAC | Class I | |
| K894362 | Model Dt-Iupc2 Transducer Tipped Dual Lumen Iup | Spectramed, LLC | KXO | Class II | |
| K894294 | Dideco-Shiley Universal Y | Shiley, Inc. | CAC | Class II | |
| K894279 | Luteinizing Hormone Mab Solid Phase Component Syst | BD Becton Dickinson Vacutainer Systems Preanalytic | CEP | Class I | |
| K894271 | Denley Wellwash 2 and 4 | Denley Instruments, Inc. | JQW | Class I | |
| K894264 | Kdf-2.3 | Unimar, Inc. | HDR | Class II | |
| K894246 | Meriview Tm Trichomonas | Meridian Diagnostics, Inc. | JWZ | Class I |