Sibel Health, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Sibel Health, Inc.” (first 2023, latest 2026), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 125 days. Since 2017 the median was 125 days, against 193 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 |
|---|---|---|
| 2023 | 1 | 241 |
| 2024 | 2 | 120 |
| 2025 | 1 | 111 |
| 2026 | 1 | 160 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sibel Health, Inc. took a median 125 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 193 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | 2 |
| DQA | Oximeter | 1 | 1 |
| HGM | System, Monitoring, Perinatal | 1 | 1 |
| MSX | System, Network And Communication, Physiological Monitors | 1 | 1 |
Review panels
Most recent Sibel Health, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253021 | ANNE Maternal | HGM | 2026-02-26 | 160 |
| K242842 | ANNE View, Central Hub | MSX | 2025-01-08 | 111 |
| K240251 | ANNE Chest | DRG | 2024-06-03 | 125 |
| K240305 | ANNE Limb | DQA | 2024-05-28 | 116 |
| K223711 | ANNE One | DRG | 2023-08-10 | 241 |
Recalls
openFDA lists no recalls under a recalling firm named Sibel Health, Inc..
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.
Device clinical trials
An industry sponsor named Sibel Health, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05693168: Accuracy of Pulse Oximeter With Profound Hypoxia (Completed, started 2021-06-23)
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.
- Sibel, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sibel Health, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Sibel Health, Inc.” (first 2023, latest 2026), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sibel Health, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sibel Health, Inc. is 125 days. Since 2017: 125 days, versus 193 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sibel Health, Inc.?
The most frequent FDA product codes under this applicant name are DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency, 2); DQA (Oximeter, 1); HGM (System, Monitoring, Perinatal, 1).
Next steps
- See all 5 Sibel Health, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRG, Sibel Health, Inc.'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.