510(k) · Cleared
ClearedBloomi Delight Oil-Based Personal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Bloomi Inc.. · NUC Lubricant, Personal
Cleared on Nov 15, 2022 as substantially equivalent to K171985 (Biofilm, Inc., 2017) after a 117-day review. Its family tree reaches back 6 generations to 1981. 2 later devices descend from it.
- Decided
- Nov 15, 2022
- Review
- 117 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K810310 (1981). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 5 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 4 generations backK061466 IntimolDlc Laboratories, Inc. · 2006
- 3 generations backK124044 Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented LubricantsSeven Oaks Ranch, Inc. · 2013
- 2 generations backK142726 O Glide Personal LubricantGrafenberg Labs · 2015
- 1 generation backK171985 Astroglide O Oil Personal Lubricant & Massage OilBiofilm, Inc. · 2017
- This deviceK222175 Bloomi Delight Oil-Based Personal LubricantThe Bloomi Inc.. · 2022
- Descendant · cites it directly · 0 of its ownK261905 BUM OilBumlicious, LLC (DBA “Bumlicious”) · 2026
- Descendant · cites it directly · 0 of its ownK232093 Woo More Play Coconut Love OilWoo Essentials, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −5 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| −4 | K061466 | Intimol | Dlc Laboratories, Inc. | 2006 | — |
| −3 | K124044 | Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented Lubricants | Seven Oaks Ranch, Inc. | 2013 | — |
| −2 | K142726 | O Glide Personal Lubricant | Grafenberg Labs | 2015 | — |
| −1 | K171985 | Astroglide O Oil Personal Lubricant & Massage Oil | Biofilm, Inc. | 2017 | — |
| 0 (this device) | K222175 | Bloomi Delight Oil-Based Personal Lubricant | The Bloomi Inc.. | 2022 | — |
| +1 | K261905 | BUM Oil | Bumlicious, LLC (DBA “Bumlicious”) | 2026 | — |
| +1 | K232093 | Woo More Play Coconut Love Oil | Woo Essentials, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K171985 | Astroglide O Oil Personal Lubricant & Massage OilSummary page 4…Predicate Device Predicate Device 510(k) Number Astroglide O Oil Personal Lubricant & Massage Oil K171985 The predicate device has not been subject to a design-related recall. V. Description of Device The… | 2017 |
What descends from it? (2)
2 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 41 years and passes through 6 companies; a new generation was cleared every 6.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K261905 (Bumlicious, LLC (DBA “Bumlicious”), 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K171985.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Bloomi Delight Oil-Based Personal Lubricant is a personal lubricant for penile and/or vaginal application, intended to lubricate, moisturize, and enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222175: Bloomi Delight Oil-Based 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/K222175
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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