510(k) · Cleared
ClearedInstead Intimate Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instead, Inc. · NUC Lubricant, Personal
Cleared on Jun 25, 2004 as substantially equivalent to K982673 (Key West Fragrance & Cosmetic, 1998) and 1 other predicate after a 205-day review. Its family tree reaches back 2 generations to 1990. 17 later devices descend from it.
- Decided
- Jun 25, 2004
- Review
- 205 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K903910 (1990). 4 ancestors in all. 17 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK903910 Lubricating JellyLake Pharmaceutical, Inc. · 1990
- 1 generation backK982673 Just Between US, Personal Lubricant & CondomKey West Fragrance & Cosmetic · 1998
- This deviceK033776 Instead Intimate LubricantInstead, Inc. · 2004
- Descendant · cites it directly · 15 of its ownK051295 I-D GlideWestridge Laboratories, Inc. · 2006
- Descendant · 2 generations on · 12 of its ownK150480 JO H20 Water Based Personal LubricantUnited Consortium, Inc. · 2015
- Descendant · 3 generations on · 9 of its ownK160211 Wet Original Personal LubricantTrigg Laboratories D/B/A Wet International · 2016
- Descendant · 4 generations on · 6 of its ownK183384 JO Agape Original Personal Lubricant, MUSE Essence Water-Based…United Consortium · 2019
- Descendant · 5 generations on · 5 of its ownK200208 Agape Warming Personal LubricantCC Wellness, LLC · 2020
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K051295I-D GlideWestridge Laboratories, Inc. · 2006 · cites it directly15descendants
- K150480JO H20 Water Based Personal LubricantUnited Consortium, Inc. · 2015 · 2 generations on12descendants
- K160211Wet Original Personal LubricantTrigg Laboratories D/B/A Wet International · 2016 · 3 generations on9descendants
- K183384JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife…United Consortium · 2019 · 4 generations on6descendants
- K200208Agape Warming Personal LubricantCC Wellness, LLC · 2020 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903910 | Lubricating Jelly | Lake Pharmaceutical, Inc. | 1990 | — |
| −1 | K982673 | Just Between US, Personal Lubricant & Condom | Key West Fragrance & Cosmetic | 1998 | — |
| 0 (this device) | K033776 | Instead Intimate Lubricant | Instead, Inc. | 2004 | — |
| +1 | K051295 | I-D Glide | Westridge Laboratories, Inc. | 2006 | — |
| +2 | K150480 | JO H20 Water Based Personal Lubricant | United Consortium, Inc. | 2015 | — |
| +3 | K160211 | Wet Original Personal Lubricant | Trigg Laboratories D/B/A Wet International | 2016 | — |
| +4 | K183384 | JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant… | United Consortium | 2019 | — |
| +5 | K200208 | Agape Warming Personal Lubricant | CC Wellness, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
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 K211998 Desnuda Reflectscore 18.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K982673 | Just Between US, Personal Lubricant & CondomSummary page 1…Person: Joe Pike, CEO/President Date of Summary: 11-18-03 Device Name: Instead Intimate Lubricant Classification Name: Lubricant (21 CFR 884.5300) Predicate Device: a. K982673 — The Just Between Us™ lubricant by Key West Fragrance & Cosmetic Factor. b. K983216 — CVS Personal Lubricant by San-Mar Laborato… | 1998 |
| * | K983216 | CVS Personal LubricantSummary page 1…ate Lubricant Classification Name: Lubricant (21 CFR 884.5300) Predicate Device: a. K982673 — The Just Between Us™ lubricant by Key West Fragrance & Cosmetic Factor. b. K983216 — CVS Personal Lubricant by San-Mar Laboratories. Intended Use: Instead Intimate Lubricant is intended to enhance the comfort an… | 1999 |
What descends from it? (17)
See all 172 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K051295 (Westridge Laboratories, Inc., 2006) has gone furthest, with 15 descendants of its own.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NUC
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NUC
221in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUC
3in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NUC
13in 2025
MAUDE reports naming product code NUC, 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 | 5 | 150 | 0 | 0 |
| 2008 | 7 | 271 | 1 | 6 |
| 2009 | 2 | — | 1 | 13 |
| 2010 | 4 | 124 | 0 | 2 |
| 2011 | 2 | — | 0 | 3 |
| 2012 | 6 | 269 | 0 | 6 |
| 2013 | 11 | 205 | 3 | 5 |
| 2014 | 11 | 264 | 0 | 14 |
| 2015 | 21 | 251 | 0 | 8 |
| 2016 | 14 | 181 | 0 | 14 |
| 2017 | 14 | 175 | 0 | 19 |
| 2018 | 15 | 114 | 0 | 6 |
| 2019 | 13 | 150 | 0 | 8 |
| 2020 | 19 | 180 | 0 | 2 |
| 2021 | 20 | 143 | 0 | 7 |
| 2022 | 14 | 112 | 0 | 7 |
| 2023 | 13 | 159 | 0 | 15 |
| 2024 | 6 | 178 | 0 | 13 |
| 2025 | 11 | 221 | 0 | 13 |
| 2026 | 12 | 104 | 0 | — |
What is it indicated for?
Instead Intimate Lubricant is intended to enhance the comfort and ease of intimate activity and is compatible with latex and polyurethane condoms.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K033776 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033776: Instead Intimate Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033776
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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