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Celerity

Model PCC0075 · ALBERT BROWNE LIMITED · DI 10724995164741

JOJ — Indicator, Physical/Chemical Sterilization Process · Class II · 21 CFR 880.2800

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.

369122019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 2.5/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/device2020-10: 0 reports for this device; peer average 4/device2020-11: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 4/device2021-06: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 3/device2021-08: 0 reports for this device; peer average 7/device2021-09: 0 reports for this device; peer average 3/device2021-10: 0 reports for this device; peer average 3.29/device2021-11: 0 reports for this device; peer average 5.67/device2021-12: 0 reports for this device; peer average 4/device2022-01: 0 reports for this device; peer average 4/device2022-02: 0 reports for this device; peer average 6/device2022-03: 0 reports for this device; peer average 12/device2022-04: 0 reports for this device; peer average 9/device2022-05: 0 reports for this device; peer average 6/device2022-06: 0 reports for this device; peer average 2/device2022-07: 0 reports for this device; peer average 2/device2022-08: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 2.25/device2023-08: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1.67/device2023-11: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 1.67/device2024-03: 0 reports for this device; peer average 1.67/device2024-04: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 1.67/device2024-12: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 2.5/device2025-07: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 2/device2025-12: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 1.5/device2026-02: 0 reports for this device; peer average 2/device2026-04: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 3/device020307080910111203060708091011120102030405060708110205081011120103040506070910111201060709101201020406
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-0302.5
2019-0701
2019-0801
2019-0901
2020-1004
2020-1101
2020-1201
2021-0304
2021-0602
2021-0703
2021-0807
2021-0903
2021-1003.29
2021-1105.67
2021-1204
2022-0104
2022-0206
2022-03012
2022-0409
2022-0506
2022-0602
2022-0702
2022-0801
2022-1101
2023-0201
2023-0502.25
2023-0801
2023-1001.67
2023-1101
2023-1201
2024-0101.67
2024-0301.67
2024-0401
2024-0502
2024-0601
2024-0701
2024-0901
2024-1002
2024-1101.67
2024-1201
2025-0102
2025-0602.5
2025-0702
2025-0901
2025-1002
2025-1202
2026-0101.5
2026-0202
2026-0401
2026-0603
This device (reports/month)Average device in JOJ (reports/device/month)

Regulatory clearances

  • K231488 SESE 2023-08-07 (k number procode)
  • K192020 SESE 2019-09-05 (k number procode)

Predicate lineage

K192020 — cites (transitively): K172746 (d1), K183295 (d1), K140515 (d2), K091174 (d3) — cited as predicate by K213262, K231488, K233187

K231488 — cites (transitively): K172746 (d1), K172753 (d1), K183293 (d1), K192020 (d1), K213262 (d1), K140515 (d2), K160485 (d2), K183295 (d2), K203284 (d2), K091174 (d3), K111519 (d3), K193110 (d3), K103219 (d4), K183211 (d4), K022441 (d5), K040742 (d5), K170321 (d5), K013228 (d6), K150622 (d6) — cited as predicate by K240760, K250044, K251452, K252680, K260766

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

Manufacturer compliance record — ALBERT BROWNE LIMITED

  • Warning Letter 2012-05-29 Albert Browne Ltd.
  • NAI 2019-09-12 Albert Browne Ltd. · 0 citations
  • OAI 2012-03-01 Albert Browne Ltd. · 8 citations