. 2021 May 6;4(5):e217274. doi: 10.1001/jamanetworkopen.2021.7274

Table 1. Overview of Device Recalls and Total Recall Events^a.

Approval pathway	Total No. of devices	Total No. (%)		Total No. of recalls	No. (%) of devices with multiple recalls	Total No. of class I recall events (% of total recalls)
Approval pathway	Total No. of devices	Recalled devices	Devices with class I recall	Total No. of recalls	No. (%) of devices with multiple recalls	Total No. of class I recall events (% of total recalls)
510(k)	28 246	3012 (10.7)	216 (0.8)	5218	960 (3.4)	269 (5.2)
PMA	310	84 (27.1)	16 (5.2)	144	26 (8.4)	28 (19.4)

Abbreviation: PMA, premarket approval.

^{^a}

Total number of devices cleared or approved for each pathway from January 1, 2008, to December 31, 2017. The recall analysis was carried out to December 31, 2019, to provide a follow-up of 2 to 12 years.

Table 1. Overview of Device Recalls and Total Recall Eventsa.

Table 1. Overview of Device Recalls and Total Recall Events^a.