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AngioSystems SorbX

Model SX5100 · ANGIOSYSTEMS, INCORPORATED · DI 00816611025673

KPY — Shield, Protective, Personnel · Class I · 21 CFR 892.6500

UDILibrary device dossier · generated 2026-09-13 · 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.

01112019-02: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1/device02060203071210
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-0601
2020-0201
2020-0301
2020-0701
2020-1201
2024-1001
This device (reports/month)Average device in KPY (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — ANGIOSYSTEMS, INCORPORATED

  • NAI 2022-09-01 AngioSystems Inc · 0 citations
  • NAI 2022-09-01 AngioSystems Inc · 0 citations
  • VAI 2015-06-18 AngioSystems Inc · 2 citations
  • VAI 2015-06-18 AngioSystems Inc · 2 citations
  • NAI 2012-02-17 AngioSystems Inc · 0 citations
  • NAI 2012-02-17 AngioSystems Inc · 0 citations
  • NAI 2010-05-28 AngioSystems Inc · 0 citations
  • NAI 2010-05-28 AngioSystems Inc · 0 citations