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Family Wellness

Model 0939504 · FOURSTAR GROUP INC. · DI 00032251057663

LCX — Kit, Test, Pregnancy, Hcg, Over The Counter · Class II · 21 CFR 862.1155

UDILibrary device dossier · generated 2026-09-12 · 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.

11222024-10: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 2/device1007
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2024-1002
2025-0702
This device (reports/month)Average device in LCX (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K150022 — cites (transitively): K123436 (d1) — cited as predicate by K232864, K234152, K240643, K243573, K251040, K251053

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

Manufacturer compliance record — FOURSTAR GROUP INC.

Nothing in the loaded window.