Therapeutic devices · 21 CFR 872 Subpart F
Fluid-Filled Teething Ring
FDA device type “Ring, Teething, Fluid-Filled”.
- Companies listing it
- 3431 makers
- Brands and models
- 43
- 510(k) clearances
- 270 in five years
- FDA name
- Ring, Teething, Fluid-Filled
510(k) clearances per year, 1976–2026
Companies that list KKO
34 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Kids II | United States | Maker | — | 2 | 2011 |
| Allied Hill Enterprises, Ltd. | Hong Kong SAR China | Maker | Handi-craft waterfill teether · Sassy Waterfill teethers | 1 | 2009 |
| Solid Toys Ind. , Ltd. | Hong Kong SAR China | Maker | Nuby · Water filledTeether | 1 | 2013 |
| Luv N' Care, Ltd. | United States | Maker | Nuby Icy Bite Gel Teether | 1 | 2010 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Ring, Teething, Fluid-Filled | — | — |
| Gavin Biotechnology Co.,ltd | China | Maker | Root canal sealer | — | — |
| Kin Sun Industrial Ltd. | Hong Kong SAR China | Maker | Chew Crew · Cuite Coolers · Ritzy Mitt · Ritzy Rattles · +1 | — | — |
| Elung Industrial Co.ltd. | China | Maker | Gel Soothers · Ice Gel Soothers · Ice Gel Teethers · Water Filled Cooling Gum Soother | — | — |
| MAM Baby AG | Switzerland | Maker | MAM Cooler, Mini Cooler, Bite & Play · MAM Twister | — | — |
| Fridababy, LLC | United States | Maker | Not-Too-Cold-To-Hold Teether | — | — |
| Ningbo Raffini Import & Export Co., Ltd | China | Maker | Teething Ring, Ring, Teething, Fluid-Filled · 53oz/15 grams all natural homeopathic formula citroganix soothing gel with silicone gume-eez teether | — | — |
| Ningbo Raffini International Enterprise Limited | China | Maker | Teething Ring, Ring, Teething, Fluid-Filled, · 53oz/15 grams all natural homeopathic formula citroganix soothing gel with silicone gume-eez teether | — | — |
| Foshan City Shunde Jiajun Plastic & Hardware Products Co Ltd | China | Maker | Hold Teether | — | — |
| Fitson Sdn Bhd | Malaysia | Maker | — | — | — |
| Chemo Mouthpiece, LLC D/B/A Ice Cold Mouthpiece | United States | Maker | Chemo Mouthpiece(TM) · Denta-Cool(TM) · Ice Cold Mouthpiece(TM) | — | — |
| Dr. Brown's Company | United States | Maker | Dr. Browns | — | — |
| Eytan Import & distribution | Israel | Maker | topmed | — | — |
| Hongkong Lute Technology CO., LIMITED | Hong Kong SAR China | Maker | Hand Teether - BY005 BY006 BY007 · Water-fillable Icy Teethers - BY001 | — | — |
| Leda Innovations USA Inc. | United States | Maker | REX ENTERPRISES CO. LTD. · Rex Enterprises Co., Ltd. | — | — |
| YI Shing Co. Ltd. | Hong Kong SAR China | Maker | Teething Ring | — | — |
| Huizhou Xinghuayuan Houseware Co., LTD | China | Maker | — | — | — |
| Itzy Ritzy | United States | Maker | Cutie Cooler | — | — |
| Sassy Baby, Inc | United States | Maker | Sassy | — | — |
| Wuhan Wei & Wen International Trading Co Ltd | China | Maker | CALA PRODUCTS | — | — |
| Zenith Baby Care Co Ltd | Thailand | Maker | Teether | — | — |
| Maggie Far East (jiujiang) Infant Products Co., Ltd | China | Maker | Ring, Teething Fluid-Filled Liquid Teether | — | — |
| Treasure Baby Toys (Dongguan) Limited | China | Maker | Playtex Baby | — | — |
| Lian Xin Toys Ltd | China | Maker | — | — | — |
| Ningbo Longwell Baby & Beauty Products Co Ltd | China | Maker | — | — | — |
| Polybell (Guangzhou) Limited | China | Maker | — | — | — |
| Wing Hing (Woo Go) Plastic Factory Limited | Hong Kong SAR China | Maker | — | — | — |
| TOMY International Inc. | Hong Kong SAR China | Foreign exporter | TOMY, The First Years, LAMAZE/JOHN DEERE RING, TEETHING, FLUID-FILLED | — | — |
| TOMY International, Inc. | United States | Lister | Liquid Filled Teether | — | — |
| Kids II Far East Limited | Hong Kong SAR China | Foreign exporter | Kids2 | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 24 May 2013 | K123855 | WATER-FILLED TEETHER | Solid Toys Ind. , Ltd. |
| 2 Dec 2011 | K110615 | WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE | Bebe Toys Manufactory , Ltd. |
| 27 Jan 2011 | K092025 | FLUID FILLED TEETHER - GEL | Kids II |
| 27 Jul 2010 | K093266 | MAM COOLER | Mam International AG |
| 23 Jun 2010 | K092781 | MAM TWISTER | Mam International AG |
| 1 Mar 2010 | K092494 | GEL FILLED GUM SOOTHER | Luv N' Care, Ltd. |
| 21 Jan 2010 | K093370 | FU HONG INDUSTRIES LIMITED SOOTHER TEETHER | Fu Hong Industries , Ltd. |
| 18 Dec 2009 | K092910 | FLUID-FILLED TEETHER | Qualiman Industrial Co., Ltd. |
| 7 Dec 2009 | K091198 | LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING | Allied Hill Enterprises, Ltd. |
| 18 Jun 2009 | K090167 | PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER, | Philips Electronics UK Limited |
| 27 May 2009 | K082824 | FLUID FILLED TEETHER | Kids II |
| 22 Apr 2009 | K083512 | FLUID-FILLED TEETHER | Wiltec Industries , Ltd. |
| 5 Nov 2007 | K072082 | GUMEASE DENTAL MOUTHPIECE | Biomedevice , Ltd. |
| 28 Jun 2006 | K052513 | BABY SNOOPY WATER FILLED TEETHER, MODEL 95367 | Delta Enterprise Corporation |
| 22 Feb 2006 | K053493 | BERRY FRUITY TEETHER | Evenflo Company, Inc. |
| 14 Dec 2005 | K052531 | FU HONG INDUSTRIES LIMITED SOOTHER TEETHER | Fu Hong Industries , Ltd. |
| 31 Oct 2005 | K052105 | WATER FILLED TEETHER | Royal Industries (Thailand) Public Co. , Ltd. |
| 22 Mar 2005 | K043033 | GLOBAL TREASURES FLUID FILLED TEETHER | Global Treasure Industries , Ltd. |
| 8 Dec 2003 | K031094 | FLUID FILLED TEETHERS | Royal King Infant Products Co. , Ltd. |
| 2 Aug 2002 | K014023 | BABY TEETHER, MODEL 20104 | Angelina Trading, Inc. |
| 14 May 2002 | K013587 | BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS | Babies Best, Inc. |
| 26 Sep 2000 | K002066 | FREEZER TEETHER | Cool Baby, Inc. |
| 16 Jun 1998 | K981202 | WATER FILLED GUM SOOTHER | Corium Corp. |
| 11 Mar 1997 | K965082 | SOOTHING WATER-FILLED TEETHER | Consolidated Stores Corp. |
| 6 Nov 1996 | K963912 | TYCO BABY SESAME STREET SOFT TEETHER | Regu-Tech Assoc., Inc. |
| 22 Dec 1995 | K955069 | PLAYSKOOL | Hasbro, Inc. |
| 3 Apr 1991 | K902974 | COOLING TEETHERS | Realgrow Intl. Corp. |
Official records: FDA product classification for KKO · 21 CFR 872.5550.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026