510(k) · Cleared

Cleared

Astroglide Brand Warming Liquid Personal Lubricant

K041432510(k) TraditionalCleared Nov 30, 2004186-day reviewClass II21 CFR 884.5300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cleared on Nov 30, 2004 as substantially equivalent to K021492 (Personal Products Co., Div. of Mcneil Ppc, Inc., 2002) after a 186-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.

Decided: Nov 30, 2004
Review: 186 days
Class: Class II
Product code: HIS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K021492 (2002). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK021492 K-Y Brand Warming Liquid Personal LubricantPersonal Products Co., Div. of Mcneil Ppc, Inc. · 2002
This deviceK041432 Astroglide Brand Warming Liquid Personal LubricantBiofilm, Inc. · 2004
Descendant · cites it directly · 0 of its ownK221036 Astroglide WarmingBiofilm, Inc. · 2022
Descendant · cites it directly · 0 of its ownK060145 FDS Intimate and Intimate Warming LubricantAlberto-Culver USA, Inc. · 2006

Most influential descendants

Showing 2 of 2 · See all

K221036Astroglide WarmingBiofilm, Inc. · 2022 · cites it directly0descendants
K060145FDS Intimate and Intimate Warming LubricantAlberto-Culver USA, Inc. · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K021492	K-Y Brand Warming Liquid Personal Lubricant	Personal Products Co., Div. of Mcneil Ppc, Inc.	2002	—
0 (this device)	K041432	Astroglide Brand Warming Liquid Personal Lubricant	Biofilm, Inc.	2004	—
+1	K221036	Astroglide Warming	Biofilm, Inc.	2022	—
+1	K060145	FDS Intimate and Intimate Warming Lubricant	Alberto-Culver USA, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2022	1	0

FIG. 1 — Lineage of K041432, 2002–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HIS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HIS device

#1 K262108 FAMA Male Latex Condoms – Aqueous Lubricant…score 13.2 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K021492	K-Y Brand Warming Liquid Personal Lubricant Summary page 1 …Personal Lubricant Classification Name Patient lubricant Predicate Device K-Y Brand WARMING LIQUID Personal Lubricant 510(k) Number K021492 Device Classification The General Hospital and Personal Use Device section of the General Medical Devices Panel has classified P…	Personal Products Co., Div. of Mcneil Ppc, Inc.	2002	—

Also cleared against K021492: 8 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K221036	Astroglide Warming	Biofilm, Inc.	2022	0
K060145	FDS Intimate and Intimate Warming Lubricant	Alberto-Culver USA, Inc.	2006	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K221036 (Biofilm, Inc., 2022) has gone furthest, with 0 descendants of its own.
8 other devices also cite its predicate K021492.

How does its category compare?

All HIS devices

HIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HIS

5in 2025

2007high 10 (2022) · low 0 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HIS

99in 2025

2007high 242 (2014) · low 54 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HIS

1in 2013

2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HIS

20in 2025

2007high 22 (2010) · low 5 (2016)2025

MAUDE reports naming product code HIS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	7	128	1	10
2008	3	157	0	11
2009	5	241	0	12
2010	1	—	0	22
2011	3	54	0	15
2012	7	106	1	10
2013	4	208	1	19
2014	7	242	0	16
2015	3	136	0	8
2016	5	115	0	5
2017	4	102	0	8
2018	2	—	0	11
2019	1	—	0	15
2020	4	240	0	12
2021	5	233	0	16
2022	10	112	0	18
2023	2	—	0	10
2024	0	—	0	7
2025	5	99	0	20
2026	2	—	0	—

What is it indicated for?

Recommended as a personal lubrication to enhance intimate activities.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041432 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041432: Astroglide Brand Warming Liquid Personal Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041432

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026