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

VERIFY

Model LCB020 · STERIS CORPORATION · DI 10724995180307

FRC — Indicator, Biological Sterilization Process · Class II · 21 CFR 880.2800

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.

13452019-01: 0 reports for this device; peer average 2/device2019-02: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 3/device2019-05: 0 reports for this device; peer average 3/device2019-06: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 3/device2019-11: 0 reports for this device; peer average 4/device2019-12: 0 reports for this device; peer average 3/device2020-01: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 3/device2020-04: 0 reports for this device; peer average 5/device2020-05: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 3/device2022-05: 0 reports for this device; peer average 2/device2022-06: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 2/device2022-09: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 3/device2023-01: 0 reports for this device; peer average 3/device2023-02: 0 reports for this device; peer average 3/device2023-03: 0 reports for this device; peer average 3/device2023-08: 0 reports for this device; peer average 2/device2023-12: 0 reports for this device; peer average 3.67/device2024-01: 0 reports for this device; peer average 4.75/device2024-02: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 3/device2025-05: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 2/device010204050607080910111201020304051001020407110205060708091001020308120102060809110508101112
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0201
2019-0403
2019-0503
2019-0601
2019-0701
2019-0801
2019-0901
2019-1003
2019-1104
2019-1203
2020-0102
2020-0201
2020-0303
2020-0405
2020-0502
2020-1001
2021-0101
2021-0201
2021-0402
2021-0701
2021-1101
2022-0203
2022-0502
2022-0601
2022-0701
2022-0802
2022-0901
2022-1003
2023-0103
2023-0203
2023-0303
2023-0802
2023-1203.67
2024-0104.75
2024-0201
2024-0601
2024-0801
2024-0902
2024-1103
2025-0501
2025-0802
2025-1001
2025-1101
2025-1202
This device (reports/month)Average device in FRC (reports/device/month)

Regulatory clearances

  • K231490 SESE 2023-08-07 (k number procode)
  • K183300 SESE 2019-01-03 (k number procode)
  • K172748 SESE 2018-02-09 (k number procode)
  • K140499 SESE 2014-07-17 (k number procode)
  • K140708 SESE 2014-06-16 (k number procode)

Predicate lineage

K090514 — cited as predicate by K120632, K131120, K140499, K140708, K141580

K140499 — cites (transitively): K073244 (d1), K083097 (d1), K090514 (d1), K092906 (d1), K102330 (d1), K103330 (d1), K103331 (d1), K062297 (d2), K070765 (d2), K070769 (d2), K090636 (d2), K052978 (d2), K503330 (d2) — cited as predicate by K171504, K172748, K173488, K183300

K140708 — cites (transitively): K073244 (d1), K090514 (d1) — cited as predicate by K173488

K172748 — cites (transitively): K140499 (d1), K140515 (d1), K073244 (d2), K083097 (d2), K090514 (d2), K092906 (d2), K102330 (d2), K103330 (d2), K103331 (d2), K091174 (d2), K062297 (d3), K070765 (d3), K070769 (d3), K090636 (d3), K052978 (d3), K503330 (d3) — cited as predicate by K183300

K183300 — cites (transitively): K140499 (d1), K140515 (d1), K172748 (d1), K182568 (d1), K073244 (d2), K083097 (d2), K090514 (d2), K092906 (d2), K102330 (d2), K103330 (d2), K103331 (d2), K091174 (d2), K140498 (d2), K162413 (d2), K172319 (d2), K062297 (d3), K070765 (d3), K070769 (d3), K090636 (d3), K052978 (d3), K503330 (d3), K102394 (d3), K131120 (d3), K111810 (d3), K112760 (d3), K112813 (d3), K120632 (d3), K160433 (d3), K090371 (d4), K103226 (d4), K071087 (d4), K013003 (d5) — cited as predicate by K231490

K231490 — cites (transitively): K140515 (d1), K183294 (d1), K183300 (d1), K091174 (d2), K171587 (d2), K172474 (d2), K172752 (d2), K173488 (d2), K181429 (d2), K140499 (d2), K172748 (d2), K182568 (d2), K073244 (d3), K083097 (d3), K090514 (d3), K092906 (d3), K102330 (d3), K103330 (d3), K103331 (d3), K123546 (d3), K162701 (d3), K163587 (d3), K171504 (d3), K140708 (d3), K140498 (d3), K162413 (d3), K172319 (d3), K062297 (d4), K070765 (d4), K070769 (d4), K090636 (d4), K052978 (d4), K503330 (d4), K004009 (d4), K103277 (d4), K102394 (d4), K131120 (d4), K111810 (d4), K112760 (d4), K112813 (d4), K120632 (d4), K160433 (d4), DEN110006 (d4), K090569 (d4), K102469 (d4), K112256 (d4), K121484 (d4), K926364 (d4), K160546 (d4), K090371 (d5), K103226 (d5), K071087 (d5), K152060 (d5), K013003 (d6), K140392 (d6), K123017 (d7), K111375 (d8) — cited as predicate by K233187, K252680

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

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