Frida
Model 100001810 · Fridababy, LLC · DI 00810028776166
PEB — Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible · Class II · 21 CFR 884.5300
UDILibrary device dossier · generated 2026-09-11 · 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.
No dated reports to chart.
Regulatory clearances
- K212705 SESE 2022-02-09 (k number procode)
Predicate lineage
K212705 — cites (transitively): K182585 (d1), K141132 (d2), K072741 (d3)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Fridababy, LLC
Nothing in the loaded window.