510(k) · Cleared
ClearedVR101 Lubricating Intravaginal Ring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J3 Bioscience, Inc. · QPD Personal Lubricant Ring
Cleared on May 20, 2021 as substantially equivalent to K101241 (Lil Drug Store Products, Inc., 2010) after a 184-day review. Its family tree reaches back 4 generations to 1981.
- Decided
- May 20, 2021
- Review
- 184 days
- Class
- Class II
- Product code
- QPD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K810310 (1981). No later device cites it as a predicate yet.
- Root · 4 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 3 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 2 generations backK062682 CVS Personal Lubricant and MoisturizerLake Consumer Products, Inc. · 2007
- 1 generation backK101241 Replens Long-Lasting Vaginal Moisturizer (Pre-Filled Applicator)Lil Drug Store Products, Inc. · 2010
- This deviceK203377 VR101 Lubricating Intravaginal RingJ3 Bioscience, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −3 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| −2 | K062682 | CVS Personal Lubricant and Moisturizer | Lake Consumer Products, Inc. | 2007 | — |
| −1 | K101241 | Replens Long-Lasting Vaginal Moisturizer (Pre-Filled Applicator) | Lil Drug Store Products, Inc. | 2010 | — |
| 0 (this device) | K203377 | VR101 Lubricating Intravaginal Ring | J3 Bioscience, Inc. | 2021 | — |
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 QPD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K101241 | Replens Long-Lasting Vaginal Moisturizer (Pre-Filled Applicator)Summary page 6…filled Applicators) – (hereafter Replens®) Manufacturer: LIL’ DRUG STORE PRODUCTS, INC. 510(k) Number: K101241 Classification Name: Condom Predicate Classification: Class II Device… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 40 years and passes through 5 companies; a new generation was cleared every 12.8 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K101241.
How does its category compare?
All QPD devicesQPD Personal Lubricant Ring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QPD
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · QPD
Too few QPD 510(k)s in any year since 2007 to give a median.
Recalls per year · QPD
No recall names QPD since 2007.
Adverse event reports per year · QPD
No MAUDE report names QPD since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
VR101 Lubricating Intravaginal Ring is a personal lubricant for 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 synthetic (polyurethane and polyisoprene) male condoms and FC2 female 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/K203377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203377: VR101 Lubricating Intravaginal Ring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203377
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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