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Steribite

Model SB70852-1 · Steribite, LLC · DI 00850003512044

HAE — Rongeur, Manual · Class II · 21 CFR 882.4840

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.

12232019-06: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1/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 1/device2021-04: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 3/device2022-06: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 2/device2024-04: 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 1/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1.5/device2026-03: 0 reports for this device; peer average 1.5/device2026-04: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 2/device06071112030410010203060103040411120102030405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0601
2019-0701
2020-1101
2020-1201
2021-0301
2021-0402
2021-1001
2022-0101
2022-0201
2022-0303
2022-0601
2023-0101
2023-0302
2023-0402
2024-0401
2025-1101
2025-1201
2026-0101
2026-0201.5
2026-0301.5
2026-0402
2026-0502
This device (reports/month)Average device in HAE (reports/device/month)

Regulatory clearances

  • K180949 SESE 2018-11-08 (k number procode)

Predicate lineage

K180949 — cites (transitively): K140927 (d1), K150428 (d1), K150468 (d1), K050438 (d2), K070106 (d2), K120867 (d2), K122211 (d2), K092227 (d2), K081651 (d2), K902819 (d3), K933978 (d3) — cited as predicate by K200768

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

Manufacturer compliance record — Steribite, LLC

  • OAI 2026-04-08 Steribite, LLC · 12 citations
  • OAI 2026-04-08 Steribite, LLC · 12 citations
  • NAI 2017-12-21 Steribite, LLC · 0 citations
  • NAI 2017-12-21 Steribite, LLC · 0 citations