美国FDA于2014年8月1日发布了“预期豁免部分II类和I类器械510K要求”草案指南。该草案指南在FDA器械数据库的16个医疗器械板块中，涉及的器械板块有11个，共涉及107个产品编码.
而FDA于2015年7月1号发布了“预期豁免部分II类和I类器械510K要求”最终指南。与原草案指南相比，涉及的器械板块还是11个，但是涉及的产品编码变为了120个（在原草案指南的基础上增加了17个产品编码，删除了4个）。
下表是最终指南与草案指南相比增加和删除的产品清单。 增加的产品编码:
| Product code
| Regulation No.
| Product name
| Dental Devices
| EIB
| 872.4565
| Syringe, Irrigating (Dental)
| Ear, Nose & Throat Devices
| EWD
| Unclassified
| Protector, Hearing (Insert)
| EWE
| Unclassified
| Protector, Hearing (Circumaural)
| LEZ
| Unclassified
| Aids, Speech Training for the Hearing Impaired (AC-Powered and Patient-Contact)
| LFA
| Unclassified
| Aids, Speech Training for the Hearing Impaired (Battery-Operated or Non-Patient)
| KLX
| 874.1325
| Electroglottograph
| LZI
| 874.3320
| Device, Assistive Listening
| Gastroenterology- Urology Devices
| LRL
| Unclassified
| Cushion, Hemorrhoid
| General Hospital and Personal Use Devices
| KMJ
| 880.6375
| Lubricant, Patient
| OYS
| 880.6760
| Patient Bed With Canopy/Restraints
| Neurological Devices
| HCD
| 882.4060
| Cannula, Ventricular
| GYK
| 882.4545
| Instrument, Shunt System Implantation
| Obstetrical and Gynecological Devices
| LHM
| 884.2982
| System, Thermographic, Liquid Crystal
| KYA
| 884.2982
| System, Thermographic Liquid Crystal, Nonpowered (Adjunctive Use)
| NUR
| 884.5435
| Pad, Menstrual, Reusable
| Ophthalmic Devices
| PJZ
| 886.1120
| Camera, Ophthalmic, AC-Powered, General-Use
| Physical Medicine Devices
| LZW
| 886.1120
| Monitor, Spine Curvature
|
删除的产品编码： Device Panel
| Product code
| Regulation No.
| Product name
| General Hospital and Personal Use Devices
| FLL
| 880.2910
| Thermometer, electronic, clinical
| Neurological Devices
| GWO
| 882.5320
| Plate,Cranioplasty, reformed, Alterable
| Ophthalmic Devices
| HKI
| 886.1120
| Camera, Ophthalmic, AC-powered
| Physical Medicine Devices
| LQX
| 890.3475
| Device, Finger-sucking
|
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