Parallax Medical, Inc.: FDA clearances and approvals
Parallax Medical, Inc. has 6 FDA 510(k) clearances (first 1999, latest 2003), across 3 product codes in 2 review panels. Median 510(k) review time: 80 days.
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 |
|---|---|---|---|
| MYU | Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty | 3 | 3 |
| KNW | Instrument, Biopsy | 2 | 2 |
| GXP | Methyl Methacrylate For Cranioplasty | 1 | 1 |
Review panels
Most recent Parallax Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033230 | TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA | MYU | 2003-12-12 | 67 |
| K023445 | TRACERS BONE CEMENT OPACIFIER | MYU | 2003-03-11 | 147 |
| K022169 | CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES | KNW | 2002-07-25 | 22 |
| K011206 | PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES | KNW | 2001-07-18 | 90 |
| K994022 | PARALLAX CRANIOSET | GXP | 2000-08-31 | 279 |
| K991893 | PARALLAX TRACER RADIOPAQUE PARTICLES | MYU | 1999-08-13 | 71 |
Recalls
openFDA lists no recalls under a recalling firm named Parallax Medical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Parallax Medical, Inc. have?
Parallax Medical, Inc. has 6 FDA 510(k) clearances (first 1999, latest 2003), across 3 product codes in 2 review panels.
How long does FDA take to clear Parallax Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Parallax Medical, Inc.'s cleared 510(k)s is 80 days.
What devices does Parallax Medical, Inc. make?
Its most frequent FDA product codes are MYU (Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty, 3); KNW (Instrument, Biopsy, 2); GXP (Methyl Methacrylate For Cranioplasty, 1).
Has Parallax Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Parallax Medical, Inc. Related entities may recall under other names.
Next steps
- See all 6 Parallax Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MYU, Parallax Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.