510(k) Report

510(k) · Cleared

Cleared

Multiple Erozone Bodyglide Fluid, Erozone Bodyglide Gel, Erozone Latex Dressing, Erozone Bodyglide Natural Foam

K040428510(k) TraditionalCleared Aug 9, 2005537-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

R & K International Cosmetics · NUC Lubricant, Personal

Cleared on Aug 9, 2005 after a 537-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.

Decided
Aug 9, 2005
Review
537 days
Class
Class II
Product code
NUC
Recalls
None
Predicates
0

4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2014: 2 descendants cleared2015: 1 descendant cleared2023: 1 descendant cleared20052010201520202025
  1. This deviceK040428 Multiple Erozone Bodyglide Fluid, Erozone Bodyglide Gel, Erozone…R & K International Cosmetics · 2005
  2. Descendant · cites it directly · 2 of its ownK133233 Pjur Original, Pjur Woman, Pjur Man Extreme GlidePjur Group Luxembourg S.A. · 2014
  3. Descendant · 2 generations on · 1 of its ownK150153 Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based…Package Solutions, LLC · 2015
  4. Descendant · 3 generations on · 0 of its ownK213892 Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & MineRb Health (Us), LLC · 2023
  5. Descendant · cites it directly · 0 of its ownK133336 Pjur (R) Siliconegel, Pjur (R) Basic Personal Glide, Pjur (R) Light…Pjur Group Luxembourg S.A. · 2014

Most influential descendants

Showing 4 of 4 · See all
  • K133233Pjur Original, Pjur Woman, Pjur Man Extreme GlidePjur Group Luxembourg S.A. · 2014 · cites it directly2descendants
  • K150153Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss…Package Solutions, LLC · 2015 · 2 generations on1descendant
  • K213892Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & MineRb Health (Us), LLC · 2023 · 3 generations on0descendants
  • K133336Pjur (R) Siliconegel, Pjur (R) Basic Personal Glide, Pjur (R) Light, Pjur (R) Med…Pjur Group Luxembourg S.A. · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K040428Multiple Erozone Bodyglide Fluid, Erozone Bodyglide Gel, Erozone Latex…R & K International Cosmetics2005—
+1K133233Pjur Original, Pjur Woman, Pjur Man Extreme GlidePjur Group Luxembourg S.A.2014—
+2K150153Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based…Package Solutions, LLC2015—
+3K213892Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & MineRb Health (Us), LLC2023—
+1K133336Pjur (R) Siliconegel, Pjur (R) Basic Personal Glide, Pjur (R) Light, Pjur (R)…Pjur Group Luxembourg S.A.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201420
201510
202310
FIG. 1 — Lineage of K040428, 2005–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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

Planning a device in NUC? 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 NUC device

  1. #1 K211998 Desnuda Reflectscore 18.6 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K133233Pjur Original, Pjur Woman, Pjur Man Extreme GlidePjur Group Luxembourg S.A.20142
K133336Pjur (R) Siliconegel, Pjur (R) Basic Personal Glide, Pjur (R) Light, Pjur (R) Med…Pjur Group Luxembourg S.A.20140

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?

  • Of its descendants, K133233 (Pjur Group Luxembourg S.A., 2014) has gone furthest, with 2 descendants of its own.

How does its category compare?

All NUC devices

NUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NUC

11in 2025

2007: 52008: 72009: 22010: 42011: 22012: 62013: 112014: 112015: 212016: 142017: 142018: 152019: 132020: 192021: 202022: 142023: 132024: 62025: 112026 (partial year): 12
2007high 21 (2015) · low 2 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NUC

221in 2025

2007: 150 days median2008: 271 days median2010: 124 days median2012: 269 days median2013: 205 days median2014: 264 days median2015: 251 days median2016: 181 days median2017: 175 days median2018: 114 days median2019: 150 days median2020: 180 days median2021: 143 days median2022: 112 days median2023: 159 days median2024: 178 days median2025: 221 days median2026 (partial year): 104 days median
2007high 271 (2008) · low 112 (2022)2026

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

Recalls per year · NUC

3in 2013

2008: 12009: 12013: 3
2007high 3 (2013) · low 0 (2007)2026

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

Adverse event reports per year · NUC

13in 2025

2008: 62009: 132010: 22011: 32012: 62013: 52014: 142015: 82016: 142017: 192018: 62019: 82020: 22021: 72022: 72023: 152024: 132025: 13
2007high 19 (2017) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007515000
2008727116
20092—113
2010412402
20112—03
2012626906
20131120535
201411264014
20152125108
201614181014
201714175019
20181511406
20191315008
20201918002
20212014307
20221411207
202313159015
20246178013
202511221013
2026121040—

What is it indicated for?

"Erozone" personal lubricants are medical devices intended for medical purposes to lubricate a body orifice to facilitate entry of a diagnotic or therapeutic device.

"Erozone" is recommended as a personal lubricant to enhance intiate activities. It is designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse. "Erozone" Personal Lubricants may be used with condoms.

Indications for use as stated in the FDA 510(k) statement.

Recent decisions in NUC

The NUC category page

  • K260117EverslideSpecial Situations, LLC · 2026
  • K253989HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU…Maxigen Biotech, Inc. · 2026
  • K261905BUM OilBumlicious, LLC (DBA “Bumlicious”) · 2026
  • K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPinkslip, LLC · 2026
  • K261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc. · 2026

https://510kreport.com/device/K040428 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040428: Multiple Erozone Bodyglide Fluid, Erozone Bodyglide Gel, Erozone Latex Dressing, Erozone Bodyglide Natural Foam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040428

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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