510(k) · Cleared
ClearedSwiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss Navy Premium All Natural Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Package Solutions, LLC · NUC Lubricant, Personal
Cleared on Oct 20, 2015 as substantially equivalent to K133233 (Pjur Group Luxembourg S.A., 2014) and 1 other predicate after a 270-day review. Its family tree reaches back 4 generations to 1990. 1 later device descends from it.
- Decided
- Oct 20, 2015
- Review
- 270 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K903910 (1990). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK903910 Lubricating JellyLake Pharmaceutical, Inc. · 1990
- 3 generations backK982673 Just Between US, Personal Lubricant & CondomKey West Fragrance & Cosmetic · 1998
- 2 generations backK033776 Instead Intimate LubricantInstead, Inc. · 2004
- 1 generation backK051295 I-D GlideWestridge Laboratories, Inc. · 2006
- This deviceK150153 Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based…Package Solutions, LLC · 2015
- Descendant · cites it directly · 0 of its ownK213892 Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & MineRb Health (Us), LLC · 2023
Most influential descendants
Showing 1 of 1 · See all- K213892Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & MineRb Health (Us), LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K903910 | Lubricating Jelly | Lake Pharmaceutical, Inc. | 1990 | — |
| −3 | K982673 | Just Between US, Personal Lubricant & Condom | Key West Fragrance & Cosmetic | 1998 | — |
| −2 | K033776 | Instead Intimate Lubricant | Instead, Inc. | 2004 | — |
| −1 | K051295 | I-D Glide | Westridge Laboratories, Inc. | 2006 | — |
| 0 (this device) | K150153 | Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based… | Package Solutions, LLC | 2015 | — |
| +1 | K213892 | Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine | Rb Health (Us), LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K133233 | Pjur Original, Pjur Woman, Pjur Man Extreme GlideSummary page 5…vice: Pjur Original Silicone Lubricant (for Swiss Navy® Premium Silicone Lubricant) Manufacturer Pjur Group, Luxembourg SA 510(k) Number: K133233 Predicate Device: ID Glide Water-Based Personal Lubricant (for Swiss Navy® Premium Water-Based Lubricant) Manufacturer… | 2014 |
| * | K051295 | I-D GlideSummary page 5…ID Glide Water-Based Personal Lubricant (for Swiss Navy® Premium Water-Based Lubricant) Manufacturer Westridge Laboratories, Inc 510(k) Number: K051295 Indications For Use: The Swiss Navy Premium Lubricants are personal lubricants for penile and / or vaginal application, intended… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213892 | Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine | 2023 | 0 |
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 25 years and passes through 5 companies; a new generation was cleared every 8.0 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K213892 (Rb Health (Us), LLC, 2023) has gone furthest, with 0 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. 2015, this device’s year, is highlighted.
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?
This is a personal lubricant 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. This is a personal lubricant for penile and / or vaginal application, intended to moisturize and…
Read the full statement (104 words)
This is a personal lubricant 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.
This is a personal lubricant 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150153 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150153: Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss Navy Premium All Natural Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150153
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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