Gorman Rupp Industries: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Gorman Rupp Industries” (first 1976, latest 1977), across 4 product codes in 4 review panels. Median 510(k) review time under this name: 20 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 |
|---|---|---|---|
| DWJ | System, Thermal Regulating | 3 | 3 |
| BSB | Warmer, Blood, Non-Electromagnetic Radiation | 1 | 1 |
| ILO | Pack, Hot Or Cold, Water Circulating | 1 | 1 |
| JRR | Regulator, Temperature | 1 | 1 |
Review panels
- Cardiovascular (3)
- Clinical Chemistry (1)
- Hematology (1)
- Physical Medicine (1)
Most recent Gorman Rupp Industries 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K771537 | AQUAMATIC K-MODULE MODEL K-20 | DWJ | 1977-09-06 | 26 |
| K770839 | AQUAMATIC K-77 | DWJ | 1977-06-08 | 30 |
| K770232 | BLOOD/FLUID WARMER MODEL DW-1000A | BSB | 1977-02-14 | 7 |
| K761337 | AQUAMATIC K-MODULE MODEL K-10 | JRR | 1977-01-10 | 14 |
| K760910 | DISPOSABLE K-PADS | ILO | 1976-12-16 | 50 |
| K761087 | ELECTRONIC CONTROL UNIT | DWJ | 1976-12-06 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Gorman Rupp Industries.
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 Gorman Rupp Industries?
FDA lists 6 510(k) clearances under the applicant name “Gorman Rupp Industries” (first 1976, latest 1977), across 4 product codes in 4 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 Gorman Rupp Industries?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gorman Rupp Industries is 20 days.
Which FDA product codes appear under Gorman Rupp Industries?
The most frequent FDA product codes under this applicant name are DWJ (System, Thermal Regulating, 3); BSB (Warmer, Blood, Non-Electromagnetic Radiation, 1); ILO (Pack, Hot Or Cold, Water Circulating, 1).
Next steps
- See all 6 Gorman Rupp Industries clearances with predicates and recalls
- Run predicate analysis for product code DWJ, Gorman Rupp Industries'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.