Fluid Filled Teether - Gel
by Kids II
510(k) K092025
Fluid Filled Teether - Gel is a medical device (FDA Class II; FDA product code KKO, Ring, Teething, Fluid-Filled) made by Kids II, cleared under FDA 510(k) K092025 on 27 Jan 2011, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK092025 | Date27 Jan 2011 | StatusActive |
Official records
- FDA 510(k) database K092025
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KKO
- Device class
- Class II
- Regulation
- 21 CFR Part 872.5550
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code KKO (Ring, Teething, Fluid-Filled).
- Water Teether / Gum Soother, Various by Babies Best, Inc.
- Mam Twister by Mam International AG
- BABY SNOOPY WATER FILLED TEETHER, MODEL 95367 by Delta Enterprise Corporation
- Philips Avent Classic Stage 2 And 3 Teether, Model SCF882/01, SCF884/01 by Philips Electronics UK Limited
- Cooling Teethers by Realgrow Intl. Corp.
- Mam Cooler by Mam International AG
- WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE by Bebe Toys Manufactory, Ltd.
- TYCO BABY SESAME STREET SOFT TEETHER by Regu-Tech Assoc., Inc.
- FLUID-FILLED TEETHER by Qualiman Industrial Co., Ltd.
- BABY TEETHER, MODEL 20104 by Angelina Trading, Inc.