Lifeline Software, Inc.

FDA Regulatory Profile

Lifeline Software, Inc. has 0 FDA recalls, 6 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 14, 2016 · NAI
Latest 510(k)
Dec 31, 2019

Updated: recalls Oct 23, 2026 · inspections Oct 23, 2026 · compliance actions Oct 23, 2026.

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Summary

Recalls
0
510(k) Clearances
3
Inspections
6
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 14, 2016Tyler, TXDevicesNo Action Indicated (NAI)3002802883
Mar 15, 2016Tyler, TXDevicesNo Action Indicated (NAI)3002802883
Nov 21, 2013Tyler, TXDevicesNo Action Indicated (NAI)3002802883
Jan 25, 2013Tyler, TXDevicesVoluntary Action Indicated (VAI)3002802883
Jun 9, 2011Tyler, TXDevicesNo Action Indicated (NAI)3002802883
Apr 20, 2010Tyler, TXDevicesNo Action Indicated (NAI)3002802883

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K193381RadCalc SoftwareDec 31, 2019
K090531RADCALC SOFTWARE, VERSION 6.0May 27, 2009
K010464RADCALC, MODEL V.4.0May 17, 2001