Prestige Ameritech Pediatric/Child’s Face mask
FDA 510(k) clearance K160100 · decided 2016-10-07
Clearance details
- K-number
- K160100
- Device name
- Prestige Ameritech Pediatric/Child’s Face mask
- Applicant
- Prestige Ameritech
- Decision
- Substantially Equivalent
- Date received
- 2016-01-19
- Decision date
- 2016-10-07
- Days to decision
- 262 days
- Clearance type
- Traditional
- Product code
- OXZ
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- North Richland Hills, TX, 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 |
|---|---|---|
| Kangbeier Child Surgical Mask (K221753) | Xinxiang Kangbeier Medical Technology Co., Ltd. | 2023-12-21 |
| PRIMED Pediatric Facemask (K213427) | Primed Medical Products, Inc. | 2022-11-22 |
| Dukal Corporation Level 1 Pediatric Face Mask (K210321) | Dukal Corporation | 2022-03-29 |
| Child Face Mask (K201514) | Shandong Shengquan New Material Co., Ltd. | 2021-10-10 |
| The iMask Child's Face Mask (K202831) | Pac-Dent, Inc. | 2021-08-26 |
| Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1) (K190308) | Amd Medicom, Inc. | 2019-09-17 |
| KIMBERLY-CLARK CHILD'S FACEMASK (K113340) | Kimberly-Clark | 2012-05-04 |
| KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK (K103150) | Kimberly-Clark | 2011-09-23 |
Recalls involving this device
No recalls on record reference this clearance.