Device class
Class II
Regulation 884.6120
Total clearances
3
2024-05-07 → 2026-04-28
Classification details
Medical specialty
Obstetrics/Gynecology
Regulation number
884.6120
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Wuhan Huchuang Union Technology Co., Ltd. |
1 |
0 |
2024-05-07 |
|
Hua Yue Medical Technology Co., Ltd. |
1 |
0 |
2025-05-22 |
|
Sheng Sheng Yi (Beijing) Technology Company Limited |
1 |
1 |
2026-04-28 |
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 |
| A4288 |
HCPCS
|
Valve for breast pump, replacement ✓ CMS-verified description |
Medium
|
Accessory, assisted reproduction, per item |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-04-28 |
K260194 |
Sheng Sheng Yi (Beijing) Technology Company Limited
|
Vacuum Pump (Model: AD-VPUM-500) |
| 2025-05-22 |
K242684 |
Hua Yue Medical Technology Co., Ltd.
|
Harioculture TL-16 Time-lapse Incubator |
| 2024-05-07 |
K232493 |
Wuhan Huchuang Union Technology Co., Ltd.
|
Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) |