FDA Product Code JOW: Sleeve, Limb, Compressible

510(k) Submission Activity

350 total 510(k) submissions under product code JOW since 1977, with 350 receiving FDA clearance (average review time: 147 days).

Submission volume has remained relatively stable over the observed period, with 14 submissions in the last 24 months.

FDA Review Time

Recent submissions under JOW have taken an average of 207 days to reach a decision - up from 145 days historically. Manufacturers should account for longer review timelines in current project planning.