Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
OXZ — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
335 daysmedian FDA review time
553 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221753 | Kangbeier Child Surgical Mask | Xinxiang Kangbeier Medical Technology Co., Ltd. | 2023-12-21 | 553 | 0 |
| K213427 | PRIMED Pediatric Facemask | Primed Medical Products, Inc. | 2022-11-22 | 397 | 0 |
| K210321 | Dukal Corporation Level 1 Pediatric Face Mask | Dukal Corporation | 2022-03-29 | 418 | 0 |
| K201514 | Child Face Mask | Shandong Shengquan New Material Co., Ltd. | 2021-10-10 | 489 | 0 |
| K202831 | The iMask Child's Face Mask | Pac-Dent, Inc. | 2021-08-26 | 335 | 0 |
| K190308 | Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Ma | Amd Medicom, Inc. | 2019-09-17 | 217 | 0 |
| K160100 | Prestige Ameritech Pediatric/Child’s Face mask | Prestige Ameritech | 2016-10-07 | 262 | 0 |
| K113340 | KIMBERLY-CLARK CHILD'S FACEMASK | Kimberly-Clark | 2012-05-04 | 172 | 0 |
| K103150 | KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK | Kimberly-Clark | 2011-09-23 | 332 | 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