510(k) · Cleared
ClearedSensua!
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aac Consulting Group, Inc. · HIS Condom
Cleared on Oct 25, 2002 as substantially equivalent to K983216 (San-Mar Laboratories, Inc., 1999) and 2 other predicates after a 200-day review. Its family tree reaches back 2 generations to 1981.
- Decided
- Oct 25, 2002
- Review
- 200 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K810310 (1981). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −1 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| 0 (this device) | K021125 | Sensua! | Aac Consulting Group, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 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 HIS? 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 HIS device
- #1 K262108 FAMA Male Latex Condoms – Aqueous Lubricant…score 13.2 · 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? (3)
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 |
|---|---|---|---|
| * | K983216 | CVS Personal LubricantSummary page 1…I 0 2 2. General Information on Device Name- SENSUA! Personal Lubricant Classification Name: Patient Lubricant 3. Predicate Devices CVS Personal Lubricant (K983216) by San Mar Labs Inc. AstroGlide Personal Lubricant (K935299) by Biofilm Inc. LubriGel (K001077) by Sheffield Labs 4. Desc… | 1999 |
| * | K935299 | AstroglideSummary page 1…al Lubricant Classification Name: Patient Lubricant 3. Predicate Devices CVS Personal Lubricant (K983216) by San Mar Labs Inc. AstroGlide Personal Lubricant (K935299) by Biofilm Inc. LubriGel (K001077) by Sheffield Labs 4. Description of the Device SENSUA! is a clear, colorless personal… | 1994 |
| * | K001077 | Lubrigel Personal LubricantSummary page 1…Patient Lubricant 3. Predicate Devices CVS Personal Lubricant (K983216) by San Mar Labs Inc. AstroGlide Personal Lubricant (K935299) by Biofilm Inc. LubriGel (K001077) by Sheffield Labs 4. Description of the Device SENSUA! is a clear, colorless personal lubricant composed o f purified water… | 2000 |
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 21 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K983216.
How does its category compare?
All HIS devicesHIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIS
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIS
99in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIS
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIS
20in 2025
MAUDE reports naming product code HIS, 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 | 7 | 128 | 1 | 10 |
| 2008 | 3 | 157 | 0 | 11 |
| 2009 | 5 | 241 | 0 | 12 |
| 2010 | 1 | — | 0 | 22 |
| 2011 | 3 | 54 | 0 | 15 |
| 2012 | 7 | 106 | 1 | 10 |
| 2013 | 4 | 208 | 1 | 19 |
| 2014 | 7 | 242 | 0 | 16 |
| 2015 | 3 | 136 | 0 | 8 |
| 2016 | 5 | 115 | 0 | 5 |
| 2017 | 4 | 102 | 0 | 8 |
| 2018 | 2 | — | 0 | 11 |
| 2019 | 1 | — | 0 | 15 |
| 2020 | 4 | 240 | 0 | 12 |
| 2021 | 5 | 233 | 0 | 16 |
| 2022 | 10 | 112 | 0 | 18 |
| 2023 | 2 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 5 | 99 | 0 | 20 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and the responsiveness (ease and comfort) during intimate sexual activity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021125: Sensua!.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021125
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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