510(k) Report

510(k) · Cleared

Cleared

JO Classic Hybrid Personal Lubricant

K181408510(k) TraditionalCleared Aug 27, 201889-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

United Consortium · NUC Lubricant, Personal

Cleared on Aug 27, 2018 as substantially equivalent to K120751 (Church & Dwight Co., Inc., 2012) after an 89-day review. Its family tree reaches back 3 generations to 1989. 4 later devices descend from it.

Decided
Aug 27, 2018
Review
89 days
Class
Class II
Product code
NUC
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K890863 (1989). 4 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared2024: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant clearedK890863 · Trojan for Women · Armkel, LLC · 1989K013614 · Trojan Crystal Clear Liquid · Armkel, LLC · 2002K120751 · Nirvana B Personal Lubricant · Church & Dwight Co., Inc. · 20121990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant K120751 · Nirvana B Personal Lubricant · Church & Dwight Co., Inc. · 2012K013614 · Trojan Crystal Clear Liquid · Armkel, LLC · 2002K890863 · Trojan for Women · Armkel, LLC · 19890
  1. Root · 3 generations backK890863 Trojan for WomenArmkel, LLC · 1989
  2. 2 generations backK013614 Trojan Crystal Clear LiquidArmkel, LLC · 2002
  3. 1 generation backK120751 Nirvana B Personal LubricantChurch & Dwight Co., Inc. · 2012
  4. This deviceK181408 JO Classic Hybrid Personal LubricantUnited Consortium · 2018
  5. Descendant · cites it directly · 3 of its ownK191480 Wet Water Based Personal Lubricant (additionally, branded as WET…Trigg Laboratories, Inc. D/B/A Wet International · 2019
  6. Descendant · 2 generations on · 1 of its ownK212000 MedleyGood Clean Love, Inc. · 2021
  7. Descendant · 2 generations on · 0 of its ownK234099 Select Hybrid Personal Lubricant, and Select Pure Silicone Personal…Select Labs, LLC · 2024
  8. Descendant · 3 generations on · 0 of its ownK222567 Playground For All Love SeshPlayground For All · 2023

Most influential descendants

Showing 4 of 4 · See all
  • K191480Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite…Trigg Laboratories, Inc. D/B/A Wet International · 2019 · cites it directly3descendants
  • K212000MedleyGood Clean Love, Inc. · 2021 · 2 generations on1descendant
  • K234099Select Hybrid Personal Lubricant, and Select Pure Silicone Personal LubricantSelect Labs, LLC · 2024 · 2 generations on0descendants
  • K222567Playground For All Love SeshPlayground For All · 2023 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K890863Trojan for WomenArmkel, LLC1989—
−2K013614Trojan Crystal Clear LiquidArmkel, LLC2002—
−1K120751Nirvana B Personal LubricantChurch & Dwight Co., Inc.2012—
0 (this device)K181408JO Classic Hybrid Personal LubricantUnited Consortium2018—
+1K191480Wet Water Based Personal Lubricant (additionally, branded as WET Platinum…Trigg Laboratories, Inc. D/B/A Wet International2019—
+2K212000MedleyGood Clean Love, Inc.2021—
+2K234099Select Hybrid Personal Lubricant, and Select Pure Silicone Personal LubricantSelect Labs, LLC2024—
+3K222567Playground For All Love SeshPlayground For All2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202110
202310
202410
FIG. 1 — Lineage of K181408, 1989–2024Source: 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 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 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K120751Nirvana B Personal Lubricant
Summary page 4
…TROJAN™ LUBRICANTS Continuous Silkiness Personal Lubricant 510(k) Number: K120751 Manufacturer: Church & Dwight Co., Inc. Product Code:…
Church & Dwight Co., Inc.2012—

Also cleared against K120751: 1 other device →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K191480Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite…Trigg Laboratories, Inc. D/B/A Wet International20193

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?

  • The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K191480 (Trigg Laboratories, Inc. D/B/A Wet International, 2019) has gone furthest, with 3 descendants of its own.
  • 1 other device also cites its predicate K120751.

How does its category compare?

All NUC devices

NUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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—

What is it indicated for?

JO Classic Hybrid Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K181408: JO Classic Hybrid 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/K181408

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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