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Bagnoli Load Cell Adapter

Model SP-X24 · DELSYS, INC. · DI 00851679007049

HCC — Device, Biofeedback · Class II · 21 CFR 882.5050

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.

23562019-03: 0 reports for this device; peer average 6/device2024-07: 0 reports for this device; peer average 1/device0307
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0306
2024-0701
This device (reports/month)Average device in HCC (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K990356 — cited as predicate by K131889, K150398

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

Manufacturer compliance record — DELSYS, INC.

  • NAI 2019-08-07 Delsys, Incorporated · 0 citations
  • NAI 2019-08-07 Delsys, Incorporated · 0 citations
  • VAI 2013-06-18 Delsys, Incorporated · 3 citations
  • VAI 2013-06-18 Delsys, Incorporated · 3 citations
  • NAI 2010-04-13 Delsys, Incorporated · 0 citations
  • NAI 2010-04-13 Delsys, Incorporated · 0 citations