BabyDance
Model 2 · FAIRHAVEN HEALTH, L.L.C. · DI 00896593002497
PEB — Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible · Class II · 21 CFR 884.5300
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.
No dated reports to chart.
Regulatory clearances
- K162319 SESE 2017-04-28 (k number procode)
Predicate lineage
K162319 — cites (transitively): K072741 (d1) — cited as predicate by K190872
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — FAIRHAVEN HEALTH, L.L.C.
Nothing in the loaded window.