Bioelectronics Corp (BIEL)

[kidnova]

They got their 510K approval by stating it was substantially equivalent to a device that was approved prior to May 28, 1976. Devices approved prior to that date were basically "grandfathered" in:

http://www.accessdata.fda.gov/cdrh_docs/pdf2/K022404.pdf

A postamendments device is one that was first distributed commercially on or after May 28, 1976. Postamendments devices that FDA determines are substantially equivalent to preamendments Class III devices are subject to the same requirements as the preamendments devices. FDA determines substantial equivalence after reviewing an applicant's premarket notification submitted in accordance with Section 510(k) of the act. Postamendments devices determined by FDA to be not substantially equivalent to either preamendments devices or postamendments devices classified into Class I or II are "new" devices and fall automatically into Class III. Before such devices can be marketed, they must have an approved premarket approval application or be reclassified into Class I (general controls) or Class II (standards).

The purpose of the reclassification process currently underway is to close this loophole in the law that allows people to use 510Ks to gain clearance based on devices that weren't subject to the full approval process required today. Likely the original device that was approved prior to 1976 wasn't required to provide a MoA.