Natural Cycles Nordic AB: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Natural Cycles Nordic AB” (first 2021, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 114 days. Since 2017 the median was 114 days, against 176 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 268 |
| 2022 | 0 | — |
| 2023 | 1 | 114 |
| 2024 | 1 | 90 |
| 2025 | 1 | 24 |
| 2026 | 1 | 238 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Natural Cycles Nordic AB took a median 114 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 176 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PYT | Device, Fertility Diagnostic, Contraceptive, Software Application | 6 | 5 |
Review panels
Most recent Natural Cycles Nordic AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253694 | Natural Cycles | PYT | 2026-07-17 | 238 |
| K250561 | Natural Cycles | PYT | 2025-03-21 | 24 |
| K241006 | Natural Cycles | PYT | 2024-07-11 | 90 |
| K231274 | Natural Cycles | PYT | 2023-08-24 | 114 |
| K202897 | Natural Cycles | PYT | 2021-06-24 | 268 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170052 | De Novo | Device, Fertility Diagnostic, Contraceptive, Software Application | 2018-08-10 |
Recalls
openFDA lists no recalls under a recalling firm named Natural Cycles Nordic AB.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Natural Technologies, Inc. (2 510(k)s)
- Natural Access (1 510(k)s)
- Natural Energy Solutions AG (1 510(k)s)
- Natural Herbal Products, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Natural Cycles Nordic AB?
FDA lists 5 510(k) clearances under the applicant name “Natural Cycles Nordic AB” (first 2021, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Natural Cycles Nordic AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Natural Cycles Nordic AB is 114 days. Since 2017: 114 days, versus 176 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Natural Cycles Nordic AB?
The most frequent FDA product codes under this applicant name are PYT (Device, Fertility Diagnostic, Contraceptive, Software Application, 6).
Next steps
- See all 5 Natural Cycles Nordic AB clearances with predicates and recalls
- Run predicate analysis for product code PYT, Natural Cycles Nordic AB's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.