AS Software, Inc.

FDA Regulatory Profile

AS Software, Inc. appears in FDA public data with 1 recall, 2 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0118-2019, Class II) was initiated on September 20, 2018. Its most recent 510(k) clearance was granted on February 19, 2026.

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0118-2019Class IIAS-OBGYN Information System version 7.824.xSeptember 20, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K260205AS Software Version AseraFebruary 19, 2026
K051639AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEMAugust 2, 2005