Ransom and Randolph: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Ransom and Randolph” (first 1976, latest 1978), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 9 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 |
|---|---|---|---|
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 | 1 |
| EHK | Cup, Prophylaxis | 1 | 1 |
| EJL | Bur, Dental | 1 | 1 |
| EKN | Point, Paper, Endodontic | 1 | 1 |
| EKP | Reamer, Pulp Canal, Endodontic | 1 | 1 |
| KDC | Instrument, Surgical, Disposable | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Ransom and Randolph 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K781605 | R&R ABSORBENT POINTS | EKN | 1978-10-10 | 22 |
| K780399 | INSTRUMENT CLEANING BRUSH | KDC | 1978-03-17 | 4 |
| K780199 | PROPHY ANGLES, R&R | EGS | 1978-02-16 | 9 |
| K780198 | PROPHY CUPS, R&R | EHK | 1978-02-16 | 9 |
| K771347 | R&R ALSTON CARBIDE BURS | EJL | 1977-08-03 | 14 |
| K770598 | ENDODONTIC INSTRUMENTS, R&R CUTWELL | EKP | 1977-04-05 | 7 |
| K761067 | DENTSPLY DIE STONE | — | 1976-11-30 | 12 |
Recalls
openFDA lists no recalls under a recalling firm named Ransom and Randolph.
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 Ransom and Randolph?
FDA lists 7 510(k) clearances under the applicant name “Ransom and Randolph” (first 1976, latest 1978), across 7 product codes in 2 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 Ransom and Randolph?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ransom and Randolph is 9 days.
Which FDA product codes appear under Ransom and Randolph?
The most frequent FDA product codes under this applicant name are EGS (Handpiece, Contra- And Right-Angle Attachment, Dental, 1); EHK (Cup, Prophylaxis, 1); EJL (Bur, Dental, 1).
Next steps
- See all 7 Ransom and Randolph clearances with predicates and recalls
- Run predicate analysis for product code EGS, Ransom and Randolph'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.