Rand Scientific Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Rand Scientific Corp.” (first 1995, latest 1996), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 46 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 |
|---|---|---|---|
| HQD | Lens, Contact (Other Material) - Daily | 2 | 2 |
| MIB | Elastomer, Silicone Block | 2 | 2 |
| EMX | Balloon, Epistaxis | 1 | 1 |
| FWP | Prosthesis, Chin, Internal | 1 | 1 |
| FZE | Prosthesis, Nose, Internal | 1 | 1 |
| HPX | Lens, Contact (Polymethylmethacrylate) | 1 | 1 |
| LZK | Implant, Malar | 1 | 1 |
| MIC | Implant, Muscle, Pectoralis | 1 | 1 |
Review panels
Most recent Rand Scientific Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K963856 | RAND NASAL PACKING | EMX | 1996-10-18 | 23 |
| K961081 | SPIRIT RIDGE SILICONE CARVING BLOCK | MIB | 1996-05-22 | 65 |
| K961057 | DURALASTIC SHEETING II | MIB | 1996-05-16 | 59 |
| K955777 | PMMA CLASIC | HPX | 1996-05-16 | 148 |
| K961124 | THE NAUTILUS | FZE | 1996-04-19 | 29 |
| K961080 | MEDIAL MALAR IMPLANT | LZK | 1996-04-19 | 32 |
| K961072 | PEC IMPLANT | MIC | 1996-04-19 | 32 |
| K961071 | THE MAGNUM CHIN IMPLANT | FWP | 1996-04-19 | 32 |
| K955366 | TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS | HQD | 1996-03-28 | 127 |
| K952165 | TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS | HQD | 1995-06-30 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Rand Scientific 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.
- Rand S.R.L. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Rand Scientific Corp.?
FDA lists 10 510(k) clearances under the applicant name “Rand Scientific Corp.” (first 1995, latest 1996), across 8 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 Rand Scientific Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rand Scientific Corp. is 46 days.
Which FDA product codes appear under Rand Scientific Corp.?
The most frequent FDA product codes under this applicant name are HQD (Lens, Contact (Other Material) - Daily, 2); MIB (Elastomer, Silicone Block, 2); EMX (Balloon, Epistaxis, 1).
Next steps
- See all 10 Rand Scientific Corp. clearances with predicates and recalls
- Run predicate analysis for product code HQD, Rand Scientific 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.