510(k) Report

510(k) · Cleared

Cleared

Gun Oil, Pink, Gun Oil H2O, Pink Water

K152918510(k) TraditionalCleared Jun 2, 2016244-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

Empowered Products, Inc. · NUC Lubricant, Personal

Cleared on Jun 2, 2016 after a 244-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.

Decided
Jun 2, 2016
Review
244 days
Class
Class II
Product code
NUC
Recalls
None
Predicates
0

6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2018: 1 descendant cleared2024: 1 descendant cleared2021: 1 descendant cleared2022: 1 descendant cleared2023: 2 descendants cleared201620182020202220242026
  1. This deviceK152918 Gun Oil, Pink, Gun Oil H2O, Pink WaterEmpowered Products, Inc. · 2016
  2. Descendant · cites it directly · 5 of its ownK180712 Coconut Infused Hybrid Personal LubricantUnited Consortium · 2018
  3. Descendant · 2 generations on · 0 of its ownK242162 Coconut HybridGood Clean Love, Inc. · 2024
  4. Descendant · 2 generations on · 0 of its ownK232091 JO Coconut Hybrid Cooling Personal LubricantCC Wellness, LLC · 2023
  5. Descendant · 2 generations on · 0 of its ownK232090 JO Coconut Hybrid Warming Personal LubricantCC Wellness, LLC · 2023
  6. Descendant · 2 generations on · 0 of its ownK221908 JO CUMPLAY Personal LubricantCC Wellness, LLC · 2022

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2018: 12021: 12022: 12023: 22024: 1
2018high 2 (2023) · low 0 (2019)2026

Most influential descendants

Showing 5 of 6 · See all
  • K180712Coconut Infused Hybrid Personal LubricantUnited Consortium · 2018 · cites it directly5descendants
  • K242162Coconut HybridGood Clean Love, Inc. · 2024 · 2 generations on0descendants
  • K232091JO Coconut Hybrid Cooling Personal LubricantCC Wellness, LLC · 2023 · 2 generations on0descendants
  • K232090JO Coconut Hybrid Warming Personal LubricantCC Wellness, LLC · 2023 · 2 generations on0descendants
  • K221908JO CUMPLAY Personal LubricantCC Wellness, LLC · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K152918Gun Oil, Pink, Gun Oil H2O, Pink WaterEmpowered Products, Inc.2016—
+1K180712Coconut Infused Hybrid Personal LubricantUnited Consortium2018—
+2K242162Coconut HybridGood Clean Love, Inc.2024—
+2K232091JO Coconut Hybrid Cooling Personal LubricantCC Wellness, LLC2023—
+2K232090JO Coconut Hybrid Warming Personal LubricantCC Wellness, LLC2023—
+2K221908JO CUMPLAY Personal LubricantCC Wellness, LLC2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202110
202210
202320
202410
FIG. 1 — Lineage of K152918, 2016–2024Source: 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? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K180712Coconut Infused Hybrid Personal LubricantUnited Consortium20185

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, K180712 (United Consortium, 2018) has gone furthest, with 5 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. 2016, this device’s year, is highlighted.

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—

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/K152918 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152918: Gun Oil, Pink, Gun Oil H2O, Pink Water.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152918

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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