Colon Therapeutics: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Colon Therapeutics” (first 1984, latest 1997), across 1 product code in 1 review panel. Median 510(k) review time under this name: 66 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 |
|---|---|---|---|
| KPL | Colonic Irrigation System | 8 | 8 |
Review panels
Most recent Colon Therapeutics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973256 | JIMMY JOHN III RECTAL NOZZLE | KPL | 1997-09-29 | 35 |
| K972455 | JIMMY JOHN III RECTAL NOZZEL, MODEL CIT | KPL | 1997-09-09 | 70 |
| K881720 | JIMMY JOHN III | KPL | 1988-07-20 | 90 |
| K873948 | MODIFIED RECTAL NOZZLE | KPL | 1987-10-14 | 16 |
| K870376 | JIMMY JOHN III, COLONIC IRRIGATION SYSTEM | KPL | 1987-03-17 | 47 |
| K870127 | MODIFIED JIMMY JOHN III | KPL | 1987-03-17 | 67 |
| K860943 | JIMMY JOHN III, RECTAL NOZZLE (MODIFICATION) | KPL | 1986-05-15 | 64 |
| K842083 | JIMMY JOHN III | KPL | 1984-10-24 | 154 |
Recalls
openFDA lists no recalls under a recalling firm named Colon Therapeutics.
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 Colon Therapeutics?
FDA lists 8 510(k) clearances under the applicant name “Colon Therapeutics” (first 1984, latest 1997), across 1 product code 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 Colon Therapeutics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Colon Therapeutics is 66 days.
Which FDA product codes appear under Colon Therapeutics?
The most frequent FDA product codes under this applicant name are KPL (Colonic Irrigation System, 8).
Next steps
- See all 8 Colon Therapeutics clearances with predicates and recalls
- Run predicate analysis for product code KPL, Colon Therapeutics'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.