注：
列表页默认显示“上市前通知”检索项下的内容；
上市前通知（510(K)）是指通过对拟上市产品与已上市产品在安全性和有效性方面进行比较，在得出实质性等同（Substantial Equivalence，简称SE）结论的前提下，进而获得拟上市产品可以合法销售的上市前通告的一条法规路径，适合于第一类、第二类、少部分三类医疗器械。
上市前批准（PMA）是FDA按照科学性和法规要求，评价第三类医疗器械安全性和有效性的审批程序。
| 器械名称 | 申请人 | 510K号码 | 类型 | 医学分类 | 收到日 | 决定日 |
|---|---|---|---|---|---|---|
| MASC Surgical Mask | 800 Greenleaf Avenue | K211984 | Traditional | SU | 2021-06-25 | 2021-07-25 |
| Altor Safety 3-Ply Surgical Mask (Model:62222) | 711 Executive Boulevard Suite C | K211249 | Traditional | SU | 2021-04-26 | 2021-07-23 |
| VS Newborn Heart Rate Monitor | Medicity, D6 Thane Road | K201887 | Traditional | CV | 2020-07-08 | 2021-07-23 |
| Blustone Synergy Diamond SA Cervical System | 5520 Ventana Ct | K210382 | Traditional | OR | 2021-02-09 | 2021-07-23 |
| HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | 174, Habuk 2-gil, Jinwi-myeon | K201160 | Traditional | SU | 2020-04-30 | 2021-07-23 |
| HMB32 Dialysis Solution | Via dell'Industria 6 | K212052 | Special | GU | 2021-06-30 | 2021-07-23 |
| Peregrine Endoscopy System | 22 HaMelacha St., POB 11384 | K202727 | Traditional | EN | 2020-09-17 | 2021-07-23 |
| MySpine WebPlanner & MyBalance | Strada Regina | K211386 | Traditional | RA | 2021-05-05 | 2021-07-23 |
| Infrared Forehead Thermometer, Model BSX976 | Rm301.3F 8th Building, LiHao Industrial Area, | K202296 | Traditional | HO | 2020-08-13 | 2021-07-23 |
| CardioCurve Steerable Sheath | 6030 West Harold Gatty Drive | K210185 | Traditional | CV | 2021-01-25 | 2021-07-23 |
| IS Multi Unit Abutment System | #204, 36, Digital-ro 27gil, Guro-gu | K210903 | Traditional | DE | 2021-03-26 | 2021-07-23 |
| GI Genius | Riverside II, Sir John Rogersons Quay | K211951 | Special | GU | 2021-06-23 | 2021-07-23 |
| SC1 Handheld Ultrasound Imaging System (Model: SC1) | B-620/621, Biz Center, 17, Techno 4-ro | K210468 | Traditional | RA | 2021-02-16 | 2021-07-23 |
| Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL) | One Thermo Fisher Way | K202612 | Traditional | MI | 2020-09-09 | 2021-07-23 |
| Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7. | 4th Floor, Building B, Zone A, Longquan Technology Park, | K210311 | Traditional | SU | 2021-02-03 | 2021-07-23 |
| Disposable IV catheter | No.77 Development Zone North Road | K202060 | Traditional | HO | 2020-07-27 | 2021-07-23 |
| da Vinci SP Surgical System (SP1098) | 1266 Kifer Road | K211316 | Traditional | GU | 2021-04-30 | 2021-07-23 |
| Klassic Knee System | 1567 E. Stratford Avenue | K211602 | Traditional | OR | 2021-05-24 | 2021-07-23 |
| Disposable Microwave Therapeutic Antennas | Third & Fourth Floors, J5 Building, No. 15 Wanshou Road, | K201265 | Traditional | SU | 2020-05-11 | 2021-07-23 |
| Flex-Thread Distal Fibula lntramedullary Nail System | 100 Witmer Road | K212030 | Special | OR | 2021-06-29 | 2021-07-23 |
