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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances
  • 510(k)K112488Substantially equivalent (SESE) · 2011-11-23clearance family

Predicate lineage

Cited as predicate by: K200446, K202197

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2024-11-27OAIOfficial action indicatedAugustine Temperature Management, LLC5
2024-11-27OAIOfficial action indicatedAugustine Temperature Management, LLC5
2024-03-21WLWarning LetterAugustine Temperature Management, LLC—
2024-03-21WLWarning LetterAugustine Temperature Management, LLC—
2023-09-19OAIOfficial action indicatedAugustine Temperature Management, LLC2
2023-09-19OAIOfficial action indicatedAugustine Temperature Management, LLC2
2017-01-04VAIVoluntary action indicatedAugustine Temperature Management, LLC3
2017-01-04VAIVoluntary action indicatedAugustine Temperature Management, LLC3
2012-09-26NAINo action indicatedAugustine Temperature Management, LLC0
2012-09-26NAINo action indicatedAugustine Temperature Management, LLC0
2012-07-24WLWarning LetterAugustine Temperature Management, LLC—
2012-07-24WLWarning LetterAugustine Temperature Management, LLC—
2010-07-14VAIVoluntary action indicatedAugustine Temperature Management, LLC7
2010-07-14VAIVoluntary action indicatedAugustine Temperature Management, LLC7
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