Arbrook Mfg. Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Arbrook Mfg. Corp.” (first 1976, latest 1979), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 21 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 |
|---|---|---|---|
| KGO | Surgeon'S Gloves | 2 | 2 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| FMC | Patient Examination Glove | 1 | 1 |
| MMK | Container, Sharps | 1 | 1 |
Review panels
- General Hospital (5)
Most recent Arbrook Mfg. Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K792016 | DISCARD-A-PAD 40-COUNT SHARPS DISPOSAL | MMK | 1979-10-26 | 21 |
| K781847 | LATEX, IN-HOUSE COMPOUNDED | KGO | 1978-11-03 | 1 |
| K781278 | GLOVES, PROCEDURE | FMC | 1978-08-31 | 37 |
| K770056 | GLOVES, SURGEONS,MICRO-TOUCH POWDERFREE | KGO | 1977-02-25 | 45 |
| K760421 | THERMOMETER, SURVALENT-ELECTRONIC | FLL | 1976-08-23 | 13 |
Recalls
openFDA lists no recalls under a recalling firm named Arbrook Mfg. 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Arbrook Mfg. Corp.?
FDA lists 5 510(k) clearances under the applicant name “Arbrook Mfg. Corp.” (first 1976, latest 1979), 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 Arbrook Mfg. Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Arbrook Mfg. Corp. is 21 days.
Which FDA product codes appear under Arbrook Mfg. Corp.?
The most frequent FDA product codes under this applicant name are KGO (Surgeon'S Gloves, 2); FLL (Continuous Measurement Thermometer, 1); FMC (Patient Examination Glove, 1).
Next steps
- See all 5 Arbrook Mfg. Corp. clearances with predicates and recalls
- Run predicate analysis for product code KGO, Arbrook Mfg. 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.