Do note that the summary pdf page is not the whole submission. 510(k)’s are hundreds of pages. I cannot speak fully for the CPAP foam, but with a predicate you

Do note that the summary pdf page is not the whole submission. 510(k)’s are hundreds of pages. I cannot speak fully for the CPAP foam, but with a predicate you still list every “material” in your device with cut sheets, etc, as well as documented biocompatibility for “airway contact” portions which include the foam. For Philips, it seems the foam degraded into a different, toxic compound which was an oversight.