Cottrell, Ltd.: FDA clearances and approvals
Cottrell, Ltd. has 9 FDA 510(k) clearances (first 1990, latest 1999), across 7 product codes in 2 review panels. Median 510(k) review time: 112 days.
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 |
|---|---|---|---|
| MED | Sterilant, Medical Devices | 3 | 3 |
| EFS | Unit, Oral Irrigation | 1 | 1 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 1 | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
| LRJ | Disinfectant, Medical Devices | 1 | 1 |
| MMN | 1 | 1 | |
| MMP | Cover, Barrier, Protective | 1 | 1 |
Review panels
- General Hospital (7)
- Dental (1)
Most recent Cottrell, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972708 | ENDO-SPOR PLUS / HYPROCIDE | MED | 1999-09-13 | 784 |
| K970726 | VAPOCIDE | MED | 1998-05-18 | 444 |
| K960089 | PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR | JOJ | 1996-04-04 | 84 |
| K952241 | PROTOUCH OVERGLOVE | MMP | 1995-08-07 | 87 |
| K952234 | BARRIER ALL FILM | EFS | 1995-07-31 | 80 |
| K932922 | PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR | MED | 1995-07-03 | 748 |
| K951983 | IMNI-II | LRJ | 1995-06-20 | 54 |
| K945575 | PRO BARRIER(TM) TUBE SOX(TM) | MMN | 1995-03-06 | 112 |
| K893802 | PROVIEW SELF-SEALING STERILIZATION POUCH | KCT | 1990-04-04 | 317 |
Recalls
openFDA lists no recalls under a recalling firm named Cottrell, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Cottrell, Ltd. have?
Cottrell, Ltd. has 9 FDA 510(k) clearances (first 1990, latest 1999), across 7 product codes in 2 review panels.
How long does FDA take to clear Cottrell, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Cottrell, Ltd.'s cleared 510(k)s is 112 days.
What devices does Cottrell, Ltd. make?
Its most frequent FDA product codes are MED (Sterilant, Medical Devices, 3); EFS (Unit, Oral Irrigation, 1); JOJ (Indicator, Physical/Chemical Sterilization Process, 1).
Has Cottrell, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cottrell, Ltd. Related entities may recall under other names.
Next steps
- See all 9 Cottrell, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MED, Cottrell, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.