510(k) · Cleared
ClearedAstroglide O Oil Personal Lubricant & Massage Oil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofilm, Inc. · NUC Lubricant, Personal
Cleared on Aug 30, 2017 as substantially equivalent to K142726 (Grafenberg Labs, 2015) after a 58-day review. Its family tree reaches back 5 generations to 1981. 4 later devices descend from it.
- Decided
- Aug 30, 2017
- Review
- 58 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. 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 4 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 3 generations backK061466 IntimolDlc Laboratories, Inc. · 2006
- 2 generations backK124044 Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented LubricantsSeven Oaks Ranch, Inc. · 2013
- 1 generation backK142726 O Glide Personal LubricantGrafenberg Labs · 2015
- This deviceK171985 Astroglide O Oil Personal Lubricant & Massage OilBiofilm, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK222175 Bloomi Delight Oil-Based Personal LubricantThe Bloomi Inc.. · 2022
- Descendant · 2 generations on · 0 of its ownK261905 BUM OilBumlicious, LLC (DBA “Bumlicious”) · 2026
- Descendant · 2 generations on · 0 of its ownK232093 Woo More Play Coconut Love OilWoo Essentials, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK180014 Creme de La Femme Feminine LubricantCewal, Inc. Dba Premiere Enterprises · 2018
Most influential descendants
Showing 4 of 4 · See all- K222175Bloomi Delight Oil-Based Personal LubricantThe Bloomi Inc.. · 2022 · cites it directly2descendants
- K261905BUM OilBumlicious, LLC (DBA “Bumlicious”) · 2026 · 2 generations on0descendants
- K232093Woo More Play Coconut Love OilWoo Essentials, Inc. · 2023 · 2 generations on0descendants
- K180014Creme de La Femme Feminine LubricantCewal, Inc. Dba Premiere Enterprises · 2018 · 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 | K061466 | Intimol | Dlc Laboratories, Inc. | 2006 | — |
| −2 | K124044 | Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented Lubricants | Seven Oaks Ranch, Inc. | 2013 | — |
| −1 | K142726 | O Glide Personal Lubricant | Grafenberg Labs | 2015 | — |
| 0 (this device) | K171985 | Astroglide O Oil Personal Lubricant & Massage Oil | Biofilm, Inc. | 2017 | — |
| +1 | K222175 | Bloomi Delight Oil-Based Personal Lubricant | The Bloomi Inc.. | 2022 | — |
| +2 | K261905 | BUM Oil | Bumlicious, LLC (DBA “Bumlicious”) | 2026 | — |
| +2 | K232093 | Woo More Play Coconut Love Oil | Woo Essentials, Inc. | 2023 | — |
| +1 | K180014 | Creme de La Femme Feminine Lubricant | Cewal, Inc. Dba Premiere Enterprises | 2018 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K142726 | O Glide Personal LubricantSummary page 4…vice Predicate Device 510(k) Number O Glide Personal Lubricant K142726 Original Applicant: Grafenberg Labs This predicate device has never been the subject of a device recall… | 2015 |
What descends from it? (4)
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 36 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, K222175 (The Bloomi Inc.., 2022) has gone furthest, with 2 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. 2017, 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?
Astroglide® O Oil Personal Lubricant & Massage Oil 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 not compatible with condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171985 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171985: Astroglide O Oil Personal Lubricant & Massage Oil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171985
Report an extraction error
Are you the manufacturer?
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