Parexel Intl. Corp.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Parexel Intl. Corp.” (first 1984, latest 1991), across 11 product codes in 5 review panels. Median 510(k) review time under this name: 80 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 |
|---|---|---|---|
| DPS | Electrocardiograph | 2 | 2 |
| DSI | Detector And Alarm, Arrhythmia | 2 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 | 2 |
| BYY | Tube, Aspirating, Flexible, Connecting | 1 | 1 |
| EAM | Screen, Intensifying, Radiographic | 1 | 1 |
| ELL | Teeth, Porcelain | 1 | 1 |
| ELM | Denture, Plastic, Teeth | 1 | 1 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 1 | 1 |
| IWZ | Film, Radiographic | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (6)
- Cardiovascular (4)
- Dental (2)
- General Hospital (1)
- General and Plastic Surgery (1)
Most recent Parexel Intl. Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K900385 | ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE | DSI | 1991-07-09 | 526 |
| K904902 | SMA 26 TRANSDUCER | ITX | 1991-03-26 | 147 |
| K904901 | L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC | ITX | 1991-03-26 | 147 |
| K884800 | ACTA GENOS ELECTROCARDIOGRAPH | DPS | 1989-06-22 | 218 |
| K862414 | FUJI CR IMAGING PLATE | EAM | 1987-02-26 | 246 |
| K864519 | PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR) | LLZ | 1987-02-13 | 88 |
| K862416 | FTI 100 MEDICAL THERMAL IMAGER | LMC | 1986-07-01 | 6 |
| K862415 | TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM | IWZ | 1986-07-01 | 6 |
| K853295 | EMODREN EXCHANGEABLE PLASTIC BELLOWS | GCY | 1985-08-20 | 14 |
| K853296 | EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN | BYY | 1985-08-15 | 9 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Parexel Intl. Corp..
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.
- Parexel International (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Parexel Intl. Corp.?
FDA lists 14 510(k) clearances under the applicant name “Parexel Intl. Corp.” (first 1984, latest 1991), across 11 product codes in 5 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 Parexel Intl. Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Parexel Intl. Corp. is 80 days.
Which FDA product codes appear under Parexel Intl. Corp.?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 2); DSI (Detector And Alarm, Arrhythmia, 2); ITX (Transducer, Ultrasonic, Diagnostic, 2).
Next steps
- See all 14 Parexel Intl. Corp. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Parexel Intl. Corp.'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.