Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KKO — Predicate Candidate Screening
27 FDA 510(k) clearances under this product code; the 50 most recent screened below.
147 daysmedian FDA review time
286 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123855 | WATER-FILLED TEETHER | Solid Toys Ind. , Ltd. | 2013-05-24 | 161 | 0 |
| K110615 | WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE | Bebe Toys Manufactory , Ltd. | 2011-12-02 | 274 | 0 |
| K092025 | FLUID FILLED TEETHER - GEL | Kids II | 2011-01-27 | 570 | 0 |
| K093266 | MAM COOLER | Mam International AG | 2010-07-27 | 281 | 0 |
| K092781 | MAM TWISTER | Mam International AG | 2010-06-23 | 286 | 0 |
| K092494 | GEL FILLED GUM SOOTHER | Luv N' Care, Ltd. | 2010-03-01 | 199 | 0 |
| K093370 | FU HONG INDUSTRIES LIMITED SOOTHER TEETHER | Fu Hong Industries , Ltd. | 2010-01-21 | 84 | 0 |
| K092910 | FLUID-FILLED TEETHER | Qualiman Industrial Co., Ltd. | 2009-12-18 | 87 | 0 |
| K091198 | LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING | Allied Hill Enterprises, Ltd. | 2009-12-07 | 227 | 0 |
| K090167 | PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01 | Philips Electronics UK Limited | 2009-06-18 | 147 | 0 |
| K082824 | FLUID FILLED TEETHER | Kids II | 2009-05-27 | 244 | 0 |
| K083512 | FLUID-FILLED TEETHER | Wiltec Industries , Ltd. | 2009-04-22 | 147 | 0 |
| K072082 | GUMEASE DENTAL MOUTHPIECE | Biomedevice , Ltd. | 2007-11-05 | 98 | 0 |
| K052513 | BABY SNOOPY WATER FILLED TEETHER, MODEL 95367 | Delta Enterprise Corporation | 2006-06-28 | 287 | 0 |
| K053493 | BERRY FRUITY TEETHER | Evenflo Company, Inc. | 2006-02-22 | 69 | 0 |
| K052531 | FU HONG INDUSTRIES LIMITED SOOTHER TEETHER | Fu Hong Industries , Ltd. | 2005-12-14 | 90 | 0 |
| K052105 | WATER FILLED TEETHER | Royal Industries (Thailand) Public Co. , Ltd. | 2005-10-31 | 89 | 0 |
| K043033 | GLOBAL TREASURES FLUID FILLED TEETHER | Global Treasure Industries , Ltd. | 2005-03-22 | 139 | 0 |
| K031094 | FLUID FILLED TEETHERS | Royal King Infant Products Co. , Ltd. | 2003-12-08 | 245 | 0 |
| K014023 | BABY TEETHER, MODEL 20104 | Angelina Trading, Inc. | 2002-08-02 | 239 | 0 |
| K013587 | BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS | Babies Best, Inc. | 2002-05-14 | 196 | 0 |
| K002066 | FREEZER TEETHER | Cool Baby, Inc. | 2000-09-26 | 81 | 0 |
| K981202 | WATER FILLED GUM SOOTHER | Corium Corp. | 1998-06-16 | 75 | 0 |
| K965082 | SOOTHING WATER-FILLED TEETHER | Consolidated Stores Corp. | 1997-03-11 | 82 | 0 |
| K963912 | TYCO BABY SESAME STREET SOFT TEETHER | Regu-Tech Assoc., Inc. | 1996-11-06 | 37 | 0 |
| K955069 | PLAYSKOOL | Hasbro, Inc. | 1995-12-22 | 46 | 0 |
| K902974 | COOLING TEETHERS | Realgrow Intl. Corp. | 1991-04-03 | 271 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda