Prentke Romich Co.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Prentke Romich Co.” (first 1990, latest 1996), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 144 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 |
|---|---|---|---|
| ILQ | System, Communication, Powered | 4 | 4 |
| IQA | System, Environmental Control, Powered | 3 | 3 |
| ITI | Wheelchair, Powered | 2 | 2 |
Review panels
Most recent Prentke Romich Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961306 | DELTATALKER WITH INFRARED | IQA | 1996-06-27 | 84 |
| K944585 | SCANNING DIRECTOR | IQA | 1995-02-21 | 155 |
| K935317 | ALPHA TALKER | ITI | 1994-03-28 | 144 |
| K933207 | WALKERTALKER | ITI | 1994-03-28 | 270 |
| K925387 | LIBERATOR | ILQ | 1993-03-29 | 154 |
| K925527 | LIGHT TALKER | ILQ | 1993-03-22 | 140 |
| K914259 | TOUCH TALKER | ILQ | 1992-02-27 | 157 |
| K902664 | HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1 | IQA | 1990-07-25 | 37 |
| K902206 | CONTROL 1 ENVIRONMENTAL CONTROL | ILQ | 1990-05-29 | 13 |
Recalls
openFDA lists no recalls under a recalling firm named Prentke Romich Co..
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 Prentke Romich Co.?
FDA lists 9 510(k) clearances under the applicant name “Prentke Romich Co.” (first 1990, latest 1996), across 3 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 Prentke Romich Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Prentke Romich Co. is 144 days.
Which FDA product codes appear under Prentke Romich Co.?
The most frequent FDA product codes under this applicant name are ILQ (System, Communication, Powered, 4); IQA (System, Environmental Control, Powered, 3); ITI (Wheelchair, Powered, 2).
Next steps
- See all 9 Prentke Romich Co. clearances with predicates and recalls
- Run predicate analysis for product code ILQ, Prentke Romich Co.'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.