Randwal Instrument Co., Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Randwal Instrument Co., Inc.” (first 1983, latest 1988), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 57 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 |
|---|---|---|---|
| HLJ | Ophthalmoscope, Battery-Powered | 2 | 2 |
| HPJ | Instrument, Visual Field, Laser | 2 | 2 |
| HLX | Photostimulator, Ac-Powered | 1 | 1 |
Plus 1 more product codes.
Review panels
- Ophthalmic (5)
Most recent Randwal Instrument Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873990 | IRAS EDS INTERFEROMETRIC STIMULATOR | HLX | 1988-02-05 | 127 |
| K873987 | IRAS GLARE TESTER | HLJ | 1987-11-24 | 56 |
| K864012 | IRAS PERIMETER | HPJ | 1986-12-12 | 58 |
| K853556 | LASER IRAS | HPJ | 1985-11-01 | 67 |
| K842567 | PORTABLE ACUIOMETER | HLJ | 1984-08-15 | 44 |
| K827577 | VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETER | — | 1983-01-24 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Randwal Instrument Co., Inc..
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 Randwal Instrument Co., Inc.?
FDA lists 6 510(k) clearances under the applicant name “Randwal Instrument Co., Inc.” (first 1983, latest 1988), across 4 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 Randwal Instrument Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Randwal Instrument Co., Inc. is 57 days.
Which FDA product codes appear under Randwal Instrument Co., Inc.?
The most frequent FDA product codes under this applicant name are HLJ (Ophthalmoscope, Battery-Powered, 2); HPJ (Instrument, Visual Field, Laser, 2); HLX (Photostimulator, Ac-Powered, 1).
Next steps
- See all 6 Randwal Instrument Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code HLJ, Randwal Instrument Co., Inc.'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.