Natural Cycles
FDA 510(k) clearance DEN170052 · decided 2018-08-10
Clearance details
- K-number
- DEN170052
- Device name
- Natural Cycles
- Applicant
- Natural Cycles Nordic AB
- Decision
- Unknown
- Date received
- 2017-09-20
- Decision date
- 2018-08-10
- Days to decision
- 324 days
- Clearance type
- Post-NSE
- Product code
- PYT
- Device class
- 2
- Regulation number
- 884.5370
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Stockholm, SE
- 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 |
|---|---|---|
| Natural Cycles (K253694) | Natural Cycles Nordic AB | 2026-07-17 |
| Natural Cycles (K250561) | Natural Cycles Nordic AB | 2025-03-21 |
| Natural Cycles (K241006) | Natural Cycles Nordic AB | 2024-07-11 |
| Natural Cycles (K231274) | Natural Cycles Nordic AB | 2023-08-24 |
| Natural Cycles (K202897) | Natural Cycles Nordic AB | 2021-06-24 |
| Clue Birth Control (K193330) | Biowink GmbH | 2021-02-18 |
Recalls involving this device
No recalls on record reference this clearance.