Oakfield Instruments, Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Oakfield Instruments, Ltd.” (first 1989, latest 1997), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 140 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 |
|---|---|---|---|
| KLA | Monitor, Esophageal Motility, Anorectal Motility, And Tube | 3 | 3 |
| FFT | Electrode, Ph, Stomach | 2 | 2 |
| IZD | Probe, Uptake, Nuclear | 2 | 2 |
| JJJ | Counter (Beta, Gamma) For Clinical Use | 1 | 1 |
Review panels
Most recent Oakfield Instruments, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964804 | FLEXILOG LS | KLA | 1997-08-06 | 250 |
| K964589 | FLEXILOG 3000 | KLA | 1997-03-04 | 109 |
| K961895 | FLEXILOG LS 13921 | KLA | 1996-11-04 | 172 |
| K945069 | FLEXILOG 2000 | FFT | 1995-06-13 | 242 |
| K920115 | MEDISCINT | IZD | 1992-03-30 | 77 |
| K902460 | CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) | IZD | 1990-08-28 | 85 |
| K896288 | FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM | FFT | 1990-05-04 | 186 |
| K894902 | SOURCERER | JJJ | 1989-10-17 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Oakfield Instruments, Ltd..
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 Oakfield Instruments, Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Oakfield Instruments, Ltd.” (first 1989, latest 1997), across 4 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 Oakfield Instruments, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oakfield Instruments, Ltd. is 140 days.
Which FDA product codes appear under Oakfield Instruments, Ltd.?
The most frequent FDA product codes under this applicant name are KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube, 3); FFT (Electrode, Ph, Stomach, 2); IZD (Probe, Uptake, Nuclear, 2).
Next steps
- See all 8 Oakfield Instruments, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KLA, Oakfield Instruments, Ltd.'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.