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 |
|---|---|---|---|---|---|
| K892105 | Patient Examination Gloves (Latex) | Essence Rubber Products Sdn Bhd | LYY | Class I | |
| K892098 | Champ-Paq Vinyl Patient Exam Gloves | Winmed Instruments Mfg. Corp. | LYZ | Class I | |
| K892090 | Sinton Latex Examination Glove | Sinton Latex Chemical Industries Co., Ltd. | LYY | Class I | |
| K892074 | Patient Examination Gloves (Latex) | Perusahaan Intan Emas Sdn. Bhd. | LYY | Class I | |
| K892009 | Patient Examination Gloves (Latex) | Glovco Malaysia Sdn Bhd | LYY | Class I | |
| K891980 | Patient Examination Glove (Latex) | Montrose Intl., Corp. | LYY | Class I | |
| K891979 | Patient Examination Glove (Latex) | Jeanine Alcantara Intl. | LYY | Class I | |
| K891797 | Dynatex Patient Examination Gloves (Latex) | Azteca Intl., Inc. | LYY | Class I | |
| K891510 | Arg Latex Examination Gloves | Palmbase Rubber Mfg. (M) Sdn Bhd | LYY | Class I | |
| K891498 | Patient Examination Gloves (Latex) | Carneal Enterprises, Inc. Div. Oakfield Mens Store | LYY | Class I | |
| K891420 | Latex Examination Gloves, Style 510 Lx | C & K Mfg. & Sales Co. | LYY | Class I | |
| K891353 | Patient Examination Gloves (Latex) | Audra, Inc. | LYY | Class I | |
| K891325 | Patient Examination Gloves (Latex) | Getah Gayal (M) Sdn Bhd | LYY | Class I | |
| K891171 | Summit Patient Examination Glove | Terng Nan Industrial Corp. | LYY | Class I | |
| K891158 | Patient Examination Glove (Latex) | Golden Earth Corp. | LYY | Class I | |
| K891147 | Patient Examination Glove (Latex) | Glove Seal Sdn Bhd | LYY | Class I | |
| K890983 | Phyne-Touch (Patient Examination Gloves) | Medical Resources, Ltd. | LYY | Class I | |
| K890965 | Patient Examination Gloves | N.S. Uni-Gloves Sdn. Bhd. | LYY | Class I | |
| K890789 | Gyroscan T5 Magnetic Resonance Diagnostic Device | Philips North America LLC | LNH | Class II | |
| K890513 | Sac 747 and Sac 847 (Sleep Analyzing Computers) | Micro Tronics Corp. | OLZ | Class II | |
| K890496 | Latex Non-Sterile Exam Gloves | Cal-American Exports, Inc. | LYY | Class I | |
| K883670 | Serological Test Kit for Igg Anti. Epstein-Barr VI | Electro-Nucleonics, Inc. | GNP | Class I | |
| K892345 | Slt Contact Laser Systems (Neurosurgery) | Surgical Laser Technologies, Inc. | GEX | Class II | |
| K892162 | Patient Exam Gloves (Mfg. Bonanza Industrial Corp) | Ing Chen Pacific Ent., Ltd. | LYY | Class I | |
| K892161 | Patient Exam Gloves (Mfg. Toong Hon Rubber Ind.) | Ing Chen Pacific Ent., Ltd. | LYY | Class I | |
| K892147 | Sentinel Latex Examination Gloves | Tai Feng Blinds Industry Co., Ltd. | LYY | Class I | |
| K892135 | Patient Examination Gloves (Latex) | Archer Exports Private, Ltd. | LYY | Class I | |
| K892053 | Respakit | Protectical Health & Safety, Ltd. | CAE | Class I | |
| K892010 | Patient Examination Gloves (Latex) | Glovco Malaysia Sdn Bhd | LYY | Class I | |
| K892008 | Patient Examination Glove (Latex) | Mediglove Sdn. Bhd. | LYY | Class I | |
| K892007 | Sentinel Latex Examination Gloves | Yeu Jeng Industrial Co., Ltd. | LYY | Class I | |
| K891796 | Disposable Latex Examination Gloves | Unitex Latex Gloves, Inc. | LYY | Class I | |
| K891712 | Perry* Latex Floor Gloves | Smith & Nephew Medical Ltd | LYY | Class I | |
| K891700 | Bodyguard Patient Examination Gloves (Latex) | Diamond Brothers Trading Co., Inc. | LYY | Class I | |
| K891442 | Patient Examination Gloves (Latex) | Orioxi Intl. Corp. | LYY | Class I | |
| K891433 | Patient Examination Glove (Latex) | Justin Intl., Inc. | LYY | Class I | |
| K891324 | Hermitex Sponge | Hermitage Hospital Products, Inc. | NAB | Class I | |
| K891172 | Latex Examination Gloves | Hofer Industries | LYY | Class I | |
| K891125 | Constrictor Ring for Penile Erection | Performance, Inc. | LKY | Class II | |
| K890871 | Bard Moss(r) Gastrostomy Tube | C.R. Bard Inc | KNT | Class II | |
| K890870 | Bard Gastrostomy Feeding Device | C.R. Bard Inc | KNT | Class II | |
| K890354 | Tegapore Wound Contact Material, Product #563X | 3M Company | NAD | Class I | |
| K890342 | Airways (Guedel, Berman & Nasopharyngeal Types) | Eastmed Enterprises, Inc. | BTO | Class II | |
| K884943 | Intermedics Select Shoulder Metal-Backed Glenoid | Intermedics Orthopedics | KWS | Class II | |
| K883080 | Sys*stim 220 | Mettler Electronics Corp | LIH | Class II | |
| K882816 | Pulsar Em | Apex Medical, Inc. | ILX | Class II | |
| K881507 | Endocoagulator Model 20 Laser & Accessories | Hgm Medical Laser Systems, Inc. | HHR | Class II | |
| K892365 | Ta Ta Latex Exam Glove | Ta TA Industrial Co., Ltd. | LYY | Class I | |
| K892226 | Tec 6340 90/15 Radiographic/fluoroscopic Table | Tecnomed, Inc. | IXR | Class II | |
| K892196 | Radkor Ts10-B | Radkor, Inc. | IXQ | Class II |