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Prolystica

Model 1C3308 · STERIS CORPORATION · DI 00724995087517

FLG — Cleaner, Ultrasonic, Medical Instrument · Class I · 21 CFR 880.6150

UDILibrary device dossier · generated 2026-09-07 · 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 (22)

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.

Malfunction: 22

23562022-07: 3 reports for this device; peer average 3/device2023-03: 3 reports for this device; peer average 3/device2023-10: 0 reports for this device; peer average 3/device2023-11: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 1/device2024-05: 1 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 3/device2024-11: 0 reports for this device; peer average 3/device2025-01: 6 reports for this device; peer average 4.5/device2025-03: 0 reports for this device; peer average 1/device2025-05: 3 reports for this device; peer average 3/device2025-09: 3 reports for this device; peer average 3/device2025-12: 0 reports for this device; peer average 1.5/device2026-03: 3 reports for this device; peer average 3/device2026-05: 0 reports for this device; peer average 1.67/device2026-06: 0 reports for this device; peer average 1/device0703101104050809110103050912030506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2022-0733
2023-0333
2023-1003
2023-1102
2024-0401
2024-0511
2024-0802
2024-0903
2024-1103
2025-0164.5
2025-0301
2025-0533
2025-0933
2025-1201.5
2026-0333
2026-0501.67
2026-0601
This device (reports/month)Average device in FLG (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — STERIS CORPORATION

  • Warning Letter 2015-02-20 Key Surgical LLC
  • Warning Letter 2014-05-22 Isomedix Operations, Inc.
  • Warning Letter 2012-05-29 Albert Browne Ltd.
  • Warning Letter 2011-02-09 Steris Corporation
  • Warning Letter 2011-02-09 Steris Corporation
  • Warning Letter 2010-09-27 Isomedix Operations, Inc.
  • Injunction 2010-04-20 Steris Corporation
  • Injunction 2010-04-20 Steris Corporation
  • Warning Letter 2009-07-31 Medivators Inc
  • NAI 2026-04-16 Steris Corporation · 0 citations
  • NAI 2026-04-16 Steris Corporation · 0 citations
  • NAI 2026-04-03 Isomedix Operations Inc. · 0 citations
  • NAI 2026-03-12 Isomedix Operations Inc · 0 citations
  • VAI 2026-02-26 Steris S.p.A. · 1 citations
  • VAI 2026-02-12 Synergy Health Ede BV · 2 citations
  • NAI 2026-02-12 Synergy Health Marseille · 0 citations
  • OAI 2025-12-12 Black Diamond Video Inc. · 3 citations
  • VAI 2025-08-01 STERIS Laboratories, Inc. · 2 citations
  • NAI 2025-06-18 Isomedix Operations Inc. · 0 citations
  • NAI 2025-06-17 Isomedix Operations Inc · 0 citations
  • NAI 2025-06-05 Isomedix Operations, Inc. · 0 citations
  • NAI 2025-04-01 Steris Corporation · 0 citations
  • NAI 2025-02-21 Isomedix Operations Inc. · 0 citations
  • NAI 2025-01-23 Synergy Health Allershausen GmbH · 0 citations
  • VAI 2024-12-12 Isomedix Operations, Inc · 0 citations
  • NAI 2024-12-05 Steris (Synergy Health Ede BV) · 0 citations
  • VAI 2024-11-21 Steris Applied Sterilization Technologies ULC · 2 citations
  • NAI 2024-09-23 Isomedix Operations, Inc. · 0 citations
  • NAI 2024-09-19 Isomedix Operations, Inc. · 0 citations