Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

AP 720S™ Semi-Automated Processor

Model 93602 · Minaris Medical America, Inc. · DI 00813382010211

DHB — System, Test, Radioallergosorbent (Rast) Immunological · Class II · 21 CFR 866.5750

UDILibrary device dossier · generated 2026-09-14 · 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.

24572019-07: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 7/device2023-03: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 3/device07020306111003
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0701
2021-0207
2023-0301
2024-0602
2024-1101
2025-1002
2026-0303
This device (reports/month)Average device in DHB (reports/device/month)

Regulatory clearances

  • K112910 SESE 2012-12-20 (k number procode)

Manufacturer compliance record — Minaris Medical America, Inc.

  • NAI 2022-12-16 Minaris Medical America, Inc. · 0 citations
  • NAI 2019-06-06 Minaris Medical America, Inc. · 0 citations
  • VAI 2015-04-21 Minaris Medical America, Inc. · 1 citations
  • VAI 2012-07-11 Minaris Medical America, Inc. · 4 citations
  • VAI 2010-08-06 Minaris Medical America, Inc. · 3 citations