Pie Medical: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Pie Medical” (first 2000, latest 2006), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 49 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 |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 5 | 5 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 5 | 5 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
Review panels
- Radiology (12)
Most recent Pie Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061961 | ART LAB SOFTWARE | LLZ | 2006-09-06 | 57 |
| K053154 | MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM | IYN | 2005-12-16 | 32 |
| K043588 | MYLAB 15 / MYLAB 20, MODEL 2700 | IYN | 2005-01-25 | 28 |
| K043360 | IMT.LAB | LLZ | 2005-01-05 | 29 |
| K041675 | PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS | IYN | 2004-07-23 | 32 |
| K033604 | TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L | IYO | 2003-12-15 | 28 |
| K023512 | PICUS ULTRASOUND IMAGING SYSTEMS | IYN | 2003-01-24 | 95 |
| K020112 | 50S TRINGA ULTRASOUND IMAGING SYSTEM | IYO | 2002-04-19 | 98 |
| K003725 | 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS | IYO | 2001-03-01 | 87 |
| K003292 | 260 CORVUS | IYO | 2001-01-05 | 77 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pie Medical.
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 Medical?
FDA lists 12 510(k) clearances under the applicant name “Pie Medical” (first 2000, latest 2006), across 3 product codes 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 Pie Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pie Medical is 49 days.
Which FDA product codes appear under Pie Medical?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 5); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 5); LLZ (System, Image Processing, Radiological, 2).
Next steps
- See all 12 Pie Medical clearances with predicates and recalls
- Run predicate analysis for product code IYN, Pie Medical'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.