Device class
Class II
Regulation 878.4040
Total clearances
5
2021-08-26 → 2023-12-21
Definition
What is Pediatric/Child Facemask
A pediatric/child facemask is intended to be worn by the patient/child to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. The facemask is recommended for use in a healthcare setting with appropriate adult supervision.
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.4040
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| A4224 |
HCPCS
|
Supplies for maintenance of insulin infusion catheter, per week ✓ CMS-verified description |
High
|
Supplies for non-invasive (eg, external) positive airway pressure device; mask and components |
Pulse
Most recent 510(k) clearances