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 |
|---|---|---|---|---|---|---|
| OXYGEN & RESUSCITATION (HOPE II MODEL) | OHIO MEDICAL PRODUCTS | K760101 | Traditional | 1976-06-23 | 1976-07-15 | |
| FILTER, BACTERIA (#2290) | INSPIRON CORP. | K760081 | Traditional | AN | 1976-06-21 | 1976-07-15 |
| CANNULA, NASAL, FOR OXYGEN | INSPIRON CORP. | K760080 | Traditional | AN | 1976-06-21 | 1976-07-15 |
| SPONGE, LAPAROTOMY GAUZE | PARKE-DAVIS CO. | K760113 | Traditional | 1976-06-24 | 1976-07-15 | |
| VALVE, I.M.V. (U-MID ONE WAY) | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | K760039 | Traditional | AN | 1976-06-15 | 1976-07-16 |
| FILTER, I.V., WITH FLASH BULB (#4701) | JELCO LABORATORIES | K760111 | Traditional | HO | 1976-06-24 | 1976-07-16 |
| ABSORBER, ANESTHESIA CIRCLE SYS, CO2 | FRASER SWEATMAN, INC. | K760076 | Traditional | AN | 1976-06-18 | 1976-07-16 |
| TRAY, BLOOD SAMPLING (PULSATOR II) | CONCORD LABORATORIES, INC. | K760086 | Traditional | CH | 1976-06-21 | 1976-07-16 |
| FLOWMETER, P.C., REDESIGNED VERSION | OHIO MEDICAL PRODUCTS | K760102 | Traditional | AN | 1976-06-23 | 1976-07-16 |
| FILTER, RESPIRATORY (U-MID) | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | K760041 | Traditional | AN | 1976-06-15 | 1976-07-16 |
| KIT, PREP SHAVE | M-C IND., INC. | K760052 | Traditional | HO | 1976-06-15 | 1976-07-16 |
| SPECTROPHOTOMETER (JUNIOR III) | THE PERKIN-ELMER CORP. | K760112 | Traditional | CH | 1976-06-24 | 1976-07-16 |
| BLOOD WARMER (CODE 4R4305) | TRAVENOL LABORATORIES, S.A. | K760012 | Traditional | HE | 1976-06-10 | 1976-07-16 |
| SPONGE, CURITY WASHED GAUZE | KENDALL RESEARCH CENTER | K760094 | Traditional | SU | 1976-06-21 | 1976-07-16 |
| FILTER, I.V. (#4700) | JELCO LABORATORIES | K760110 | Traditional | HO | 1976-06-24 | 1976-07-16 |
| TEST, RIA, SERUM DIGOXIN | SMITH KLINE DIAGNOSTICS, INC. | K760077 | Traditional | TX | 1976-06-18 | 1976-07-16 |
| CAP, INJECTION (#4600) | JELCO LABORATORIES | K760103 | Traditional | HO | 1976-06-23 | 1976-07-16 |
| SURGICAL BLADES (BEAVER) | PARKE-DAVIS CO. | K760016 | Traditional | 1976-06-11 | 1976-07-16 | |
| BOTTLE, CONDENSATE (#1628) | INSPIRON CORP. | K760082 | Traditional | HO | 1976-06-21 | 1976-07-16 |
| HEATER, IMMERSION W/ HUMIDIFIER & NEBUL. | INSPIRON CORP. | K760037 | Traditional | AN | 1976-06-15 | 1976-07-16 |
