Pre-Seed™ Personal Lubricant Fertility Friendly
Model 00855114000992 · CHURCH & DWIGHT CO., INC. · DI 00855114000992
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
- K193450 SESE 2020-07-23 (k number procode)
Predicate lineage
K072741 — cited as predicate by K131355, K141132, K162319, K193450
K193450 — cites (transitively): K072741 (d1)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — CHURCH & DWIGHT CO., INC.
- Warning Letter 2011-05-16 Church & Dwight Inc
- Warning Letter 2011-05-16 Church & Dwight Inc
- NAI 2024-08-12 Church & Dwight Manufacturing Co., Ltd. · 0 citations
- NAI 2024-07-18 Church & Dwight Canada Corp. · 0 citations
- NAI 2023-08-08 Church & Dwight Manufacturing Co., Ltd. · 0 citations
- NAI 2022-07-15 Church & Dwight Manufacturing Co., Ltd. · 0 citations
- NAI 2020-08-14 Church & Dwight Inc · 0 citations
- NAI 2020-08-14 Church & Dwight Inc · 0 citations
- VAI 2017-10-31 Church & Dwight Manufacturing Co., Ltd. · 1 citations
- NAI 2015-08-06 Church & Dwight Inc · 0 citations
- NAI 2015-08-06 Church & Dwight Inc · 0 citations
- VAI 2015-03-13 Church & Dwight Manufacturing Co., Ltd. · 2 citations
- VAI 2012-08-24 Church & Dwight Manufacturing Co., Ltd. · 2 citations
- VAI 2012-02-13 Church & Dwight Inc · 5 citations
- VAI 2012-02-13 Church & Dwight Inc · 5 citations
- NAI 2011-02-17 Church & Dwight Co., Inc. · 0 citations
- OAI 2011-02-17 Church & Dwight Inc · 7 citations
- OAI 2011-02-17 Church & Dwight Inc · 7 citations
- VAI 2010-07-08 Church & Dwight Manufacturing Co., Ltd. · 3 citations