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# Five Class 2 Devices Exempt from 510(k)
- URL: https://www.fdaweb.com/five-class-2-devices-exempt-from-510-k/
- Published: 2019-10-25T12:00:00.000Z
- Updated: 2026-09-15T01:58:54.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145343

*Federal Register* notice: FDA has announced its decision to exempt a list of Class 2 devices from premarket notification requirements. Comments are being accepted until 12/24 on the exempt devices. They are:

- Accessory, Assisted Reproduction (product code MQG): Exemption is limited to assisted reproduction laminar flow workstations
- Media, Reproductive (product code MQL): Exemption is limited to phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications.
- Instruments Designed for Press-Fit Osteochondral implants (product code QBO)
- System, Optical Position/Movement Recording — Interactive Rehabilitation Exercise Devices (product code LXJ): Exemption is limited to prescription-use only
- Massager, Therapeutic, to Internally Massage Trigger Points in the Pelvic Floor Musculature (product code OSD)

To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-10-25/pdf/2019-23308.pdf?ref=fdaweb.com).