510(k) · Cleared
ClearedPulse H20h!
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toaster Labs, Inc. · NUC Lubricant, Personal
Cleared on Jul 11, 2016 as substantially equivalent to K122476 (Ansell Healthcare Products, LLC, 2013) after a 300-day review. Its family tree reaches back 5 generations to 1981. 1 later device descends from it.
- Decided
- Jul 11, 2016
- Review
- 300 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K810310 (1981). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 4 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 3 generations backK032124 Durex Play LubricantSsl Americas, Inc. · 2004
- 2 generations backK060098 Durex Play Temptations Assorted LubricantsSsl Americas, Inc. · 2006
- 1 generation backK122476 Lifestyles Smooth 2-in-1 Massage & LubricantAnsell Healthcare Products, LLC · 2013
- This deviceK152628 Pulse H20h!Toaster Labs, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK202017 Passion Natural Water Based LubricantXr, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K202017Passion Natural Water Based LubricantXr, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −4 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| −3 | K032124 | Durex Play Lubricant | Ssl Americas, Inc. | 2004 | — |
| −2 | K060098 | Durex Play Temptations Assorted Lubricants | Ssl Americas, Inc. | 2006 | — |
| −1 | K122476 | Lifestyles Smooth 2-in-1 Massage & Lubricant | Ansell Healthcare Products, LLC | 2013 | — |
| 0 (this device) | K152628 | Pulse H20h! | Toaster Labs, Inc. | 2016 | — |
| +1 | K202017 | Passion Natural Water Based Lubricant | Xr, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K122476 | Lifestyles Smooth 2-in-1 Massage & LubricantSummary page 4…e Name: LifeStyles® Smooth™ 2-in-1 Device Massage & Lubricant 510(k) number: K122476 Manufacturer: Ansell Healthcare Products, LLC Regulation: 21 C… | 2013 |
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 |
|---|---|---|---|
| K202017 | Passion Natural Water Based Lubricant | 2021 | 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 35 years and passes through 5 companies; a new generation was cleared every 6.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K202017 (Xr, LLC, 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K122476.
How does its category compare?
All NUC devicesNUC 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
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?
The Pulse™ H2Oh! personal lubricant is intended for vaginal and/or penile application to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity, and supplement the body’s natural lubrication.
This personal lubricant 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.
https://510kreport.com/device/K152628 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152628: Pulse H20h!.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152628
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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