510(k) Report

510(k) · Cleared

Cleared

Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented Lubricants

K124044510(k) TraditionalCleared Aug 30, 2013242-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

Seven Oaks Ranch, Inc. · NUC Lubricant, Personal

Cleared on Aug 30, 2013 as substantially equivalent to K061466 (Dlc Laboratories, Inc., 2006) after a 242-day review. Its family tree reaches back 3 generations to 1981. 23 later devices descend from it.

Decided
Aug 30, 2013
Review
242 days
Class
Class II
Product code
NUC
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K810310 (1981). 5 ancestors in all. 23 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1996: 1 other ancestor2016: 1 descendant cleared2017: 3 descendants cleared2015: 2 descendants cleared2019: 3 descendants cleared2022: 2 descendants cleared2014: 1 descendant cleared2018: 3 descendants cleared2026: 3 descendants cleared2020: 1 descendant cleared2025: 2 descendants cleared2021: 1 descendant cleared2023: 1 descendant clearedK810310 · K-Y Lubricating Jelly · Johnson & Johnson Professionals, Inc. · 1981K935299 · Astroglide · Biofilm, Inc. · 1994K061466 · Intimol · Dlc Laboratories, Inc. · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors 1 generation forward: 9 descendants2 generations forward: 7 descendants3 generations forward: 5 descendants4 generations forward: 2 descendants K061466 · Intimol · Dlc Laboratories, Inc. · 2006K935299 · Astroglide · Biofilm, Inc. · 1994K810310 · K-Y Lubricating Jelly · Johnson & Johnson Professionals, Inc. · 19810
  1. Root · 3 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
  2. 2 generations backK935299 AstroglideBiofilm, Inc. · 1994
  3. 1 generation backK061466 IntimolDlc Laboratories, Inc. · 2006
  4. This deviceK124044 Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented LubricantsSeven Oaks Ranch, Inc. · 2013
  5. Descendant · cites it directly · 5 of its ownK142726 O Glide Personal LubricantGrafenberg Labs · 2015
  6. Descendant · 2 generations on · 4 of its ownK171985 Astroglide O Oil Personal Lubricant & Massage OilBiofilm, Inc. · 2017
  7. Descendant · cites it directly · 3 of its ownK141034 Azul Personal LubricantChurch & Dwight Co., Inc. · 2014
  8. Descendant · 3 generations on · 2 of its ownK222175 Bloomi Delight Oil-Based Personal LubricantThe Bloomi Inc.. · 2022
  9. Descendant · cites it directly · 2 of its ownK182027 Wet Organics Personal LubricantTrigg Laboratories Dba Wet International · 2018

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2014: 12015: 22016: 12017: 32018: 32019: 32020: 12021: 12022: 22023: 12025: 22026: 3
2014high 3 (2017) · low 0 (2024)2026

Most influential descendants

Showing 5 of 23 · See all
  • K142726O Glide Personal LubricantGrafenberg Labs · 2015 · cites it directly5descendants
  • K171985Astroglide O Oil Personal Lubricant & Massage OilBiofilm, Inc. · 2017 · 2 generations on4descendants
  • K141034Azul Personal LubricantChurch & Dwight Co., Inc. · 2014 · cites it directly3descendants
  • K222175Bloomi Delight Oil-Based Personal LubricantThe Bloomi Inc.. · 2022 · 3 generations on2descendants
  • K182027Wet Organics Personal LubricantTrigg Laboratories Dba Wet International · 2018 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K810310K-Y Lubricating JellyJohnson & Johnson Professionals, Inc.1981—
−2K935299AstroglideBiofilm, Inc.1994—
−1K061466IntimolDlc Laboratories, Inc.2006—
0 (this device)K124044Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented LubricantsSeven Oaks Ranch, Inc.2013—
+1K142726O Glide Personal LubricantGrafenberg Labs2015—
+2K171985Astroglide O Oil Personal Lubricant & Massage OilBiofilm, Inc.2017—
+1K141034Azul Personal LubricantChurch & Dwight Co., Inc.2014—
+3K222175Bloomi Delight Oil-Based Personal LubricantThe Bloomi Inc..2022—
+1K182027Wet Organics Personal LubricantTrigg Laboratories Dba Wet International2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201520
201610
201730
201830
201930
202010
202110
202220
202310
202520
202630
FIG. 1 — Lineage of K124044, 1981–2026Source: 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
Get a 510(k) Report

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
*K061466Intimol
Summary page 1
…e: Condom Panel: Obstetrics/Gynecology Product Code: NUC Predicate Device: K06 1466 - INTIMOLTM Liquid Personal Lubricant (DLC Laboratories, Inc.) Indication for Use: Aloe Ca…
Dlc Laboratories, Inc.2006—

What descends from it? (23)

See all 23

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

NumberDeviceApplicantDecidedDescendants
K142726O Glide Personal LubricantGrafenberg Labs20155
K141034Azul Personal LubricantChurch & Dwight Co., Inc.20143
K182027Wet Organics Personal LubricantTrigg Laboratories Dba Wet International20182
K162569YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal…Biotech Lubricants, Ltd.20172
K150094Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon VanillaGood Clean Love, Inc.20152
K220534Wet Essential95 Personal LubricantTrigg Laboratories, Inc.20220
K190323Aloe Glide LubricantDesert Harvest, Inc.20190
K183050GLISSANT Intimate LubricantVjuvenate, LLC20190
K152646Sylk Personal LubricantToro Management, LLC Dba Sylk20160

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 32 years and passes through 4 companies; a new generation was cleared every 12.8 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K142726 (Grafenberg Labs, 2015) 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. 2013, 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?

Aloe Cadabrag Lubricant and Aloe Cadabra@ Flavored/Scented Lubricants are personal lubricants, for penile and/or vaginal application, intended to moisturize and lubricate, 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.

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/K124044 · printed Nov 6, 2026

Cite this page

510(k) Report. “K124044: Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented Lubricants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K124044

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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