Atlas FDA

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

+ Add to Predicate Builder ◉ Watch Natural Cycles Nordic AB

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Natural Cycles (K253694)Natural Cycles Nordic AB2026-07-17
Natural Cycles (K250561)Natural Cycles Nordic AB2025-03-21
Natural Cycles (K241006)Natural Cycles Nordic AB2024-07-11
Natural Cycles (K231274)Natural Cycles Nordic AB2023-08-24
Natural Cycles (K202897)Natural Cycles Nordic AB2021-06-24
Clue Birth Control (K193330)Biowink GmbH2021-02-18

Recalls involving this device

No recalls on record reference this clearance.