Pre-Seed™ Fertility Lubricant
FDA 510(k) clearance K193450 · decided 2020-07-23
Clearance details
- K-number
- K193450
- Device name
- Pre-Seed™ Fertility Lubricant
- Applicant
- Church & Dwight Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-12-13
- Decision date
- 2020-07-23
- Days to decision
- 223 days
- Clearance type
- Traditional
- Product code
- PEB
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Ewing, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Actively Trying Personal Lubricant Rose Scented (K212885) | CC Wellness, LLC | 2022-02-11 |
| Actively Trying Personal Lubricant Unfragrance (K212705) | CC Wellness, LLC | 2022-02-09 |
| BioGenesis Fertility Lubricant (K190872) | Good Clean Love, Inc. | 2019-11-07 |
| JO Actively Trying Personal Lubricant (K182585) | United Consortium | 2019-04-26 |
| BabyDance Fertility Lubricant (K162319) | Fairhaven Health, LLC | 2017-04-28 |
| ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT (K141132) | Biofilm, Inc. | 2015-01-09 |
| CONCEIVE PLUS (K131355) | Sasmar, Inc. | 2013-11-07 |
| PRE-VA VAGINAL LUBRICANT (K072741) | Ingfertility, LLC | 2008-07-16 |
| PRE' VAGINAL LUBRICANT (K051436) | Ingfertlity, LLC | 2006-10-13 |
Recalls involving this device
No recalls on record reference this clearance.