Pie Data Medical BV: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Pie Data Medical BV” (first 1987, latest 1988), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 279 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNG | Monitor, Ultrasonic, Fetal | 2 | 2 |
| HGM | System, Monitoring, Perinatal | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| LWI | Ultrasound, Sinus | 1 | 1 |
Review panels
Most recent Pie Data Medical BV 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K874192 | MULTIPURPOSE TRANSDUCER RANGE | IYO | 1988-07-19 | 279 |
| K870653 | ULTRASOUND LINEAR/SECTOR SCANNER 1100 | KNG | 1988-02-02 | 350 |
| K870058 | PIE MEDICAL SCANNER 1000 | KNG | 1988-02-02 | 391 |
| K874081 | ENTERSCAN | LWI | 1987-12-31 | 85 |
| K871082 | FETAL CARE MONITOR ANTEPARTUM 1500 | HGM | 1987-08-04 | 139 |
Recalls
openFDA lists no recalls under a recalling firm named Pie Data Medical BV.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Pie Data Medical BV?
FDA lists 5 510(k) clearances under the applicant name “Pie Data Medical BV” (first 1987, latest 1988), 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 Pie Data Medical BV?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pie Data Medical BV is 279 days.
Which FDA product codes appear under Pie Data Medical BV?
The most frequent FDA product codes under this applicant name are KNG (Monitor, Ultrasonic, Fetal, 2); HGM (System, Monitoring, Perinatal, 1); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 1).
Next steps
- See all 5 Pie Data Medical BV clearances with predicates and recalls
- Run predicate analysis for product code KNG, Pie Data Medical BV'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.