Astroglide TTC - Trying to Conceive
Model 015594011226 · BIOFILM, INC · DI 00015594011226
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
- K141132 SESE 2015-01-09 (k number procode)
Predicate lineage
K141132 — cites (transitively): K072741 (d1) — cited as predicate by K182585
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — BIOFILM, INC
- VAI 2026-05-19 Biofilm, Inc. · 1 citations
- VAI 2023-06-15 Biofilm, Inc. · 0 citations
- VAI 2017-05-25 Biofilm, Inc. · 4 citations
- NAI 2011-09-14 Biofilm, Inc. · 0 citations
- VAI 2011-06-01 Biofilm, Inc. · 1 citations