Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Actherm, Inc. · Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

36 daysmedian FDA review time
239 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K093795ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PRActherm, Inc.2010-03-12920
K083419ACTHERM DIGITAL CLINICAL THERMOMETER PROBE COVERS, MODEL(S) Actherm, Inc.2009-07-162390
K090031ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES; PROBE COVActherm, Inc.2009-04-161010
K070028CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED,Actherm, Inc.2007-02-08360
K031905DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT Actherm, Inc.2003-07-07170
K021612DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038Actherm, Inc.2002-05-30140
K021614DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020Actherm, Inc.2002-05-30140
K010238ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT201Actherm, Inc.2001-02-06120

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda