Device class
Class II
Regulation 884.5370
Total clearances
6
2021-02-18 → 2026-07-17
Definition
What is Device, Fertility Diagnostic, Contraceptive, Software Application
Designed to monitor and provide fertility information to prevent pregnancy (contraception).
Classification details
Medical specialty
Obstetrics/Gynecology
Regulation number
884.5370
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 |
| 99458 |
CPT
|
— |
Medium
|
Digital/remote therapeutic monitoring for chronic disease management if fertility app-based |
| 99499 |
CPT
|
— |
Medium
|
Unlisted evaluation and management code for fertility monitoring and contraceptive counseling |
Pulse
Most recent 510(k) clearances