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RELIEVA LUMA SENTRY

Model SIS100BZ · ACCLARENT, INC. · DI 20705031135649

KAM — Cannula, Sinus · Class I · 21 CFR 878.4800

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.

No dated reports to chart.

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K071845 — cited as predicate by K110158, K111763, K120280, K143541

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — ACCLARENT, INC.

  • Warning Letter 2013-03-20 Acclarent, Inc.
  • Warning Letter 2013-03-20 Acclarent, Inc.
  • Warning Letter 2012-06-14 Acclarent, Inc.
  • Warning Letter 2012-06-14 Acclarent, Inc.
  • NAI 2020-09-25 Acclarent, Inc. · 0 citations
  • NAI 2020-09-25 Acclarent, Inc. · 0 citations
  • VAI 2013-12-09 Acclarent, Inc. · 0 citations
  • VAI 2013-12-09 Acclarent, Inc. · 0 citations
  • OAI 2013-02-22 Acclarent, Inc. · 2 citations
  • OAI 2013-02-22 Acclarent, Inc. · 2 citations
  • OAI 2012-02-24 Acclarent, Inc. · 3 citations
  • OAI 2012-02-24 Acclarent, Inc. · 3 citations