Dalton Instrument Corp.: FDA clearances and approvals
Dalton Instrument Corp. has 5 FDA 510(k) clearances (first 1985, latest 2014), across 4 product codes in 2 review panels. Median 510(k) review time: 113 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 243 |
| 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 |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | 2 | 2 |
| CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | 1 | 1 |
| INO | Chair, Positioning, Electric | 1 | 1 |
| ITI | Wheelchair, Powered | 1 | 1 |
Review panels
- Physical Medicine (4)
- Anesthesiology (1)
Most recent Dalton Instrument Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131909 | DALTON LIFT CHAIR | INO | 2014-02-24 | 243 |
| K101611 | RELAY POWER WHEELCHAIR | ITI | 2010-09-29 | 113 |
| K101719 | TACAMO MANUAL WHEELCHAIR | IOR | 2010-08-25 | 68 |
| K904843 | OSCAR(TM) II CAPNOMETER & PULSE OXIMETER | CBR | 1991-04-09 | 166 |
| K850178 | DALTON FOLDING WHEELCHAIRS | IOR | 1985-04-25 | 98 |
Recalls
openFDA lists no recalls under a recalling firm named Dalton Instrument Corp..
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 Dalton Instrument Corp. have?
Dalton Instrument Corp. has 5 FDA 510(k) clearances (first 1985, latest 2014), across 4 product codes in 2 review panels.
How long does FDA take to clear Dalton Instrument Corp.'s 510(k)s?
The median time from FDA receipt to decision across Dalton Instrument Corp.'s cleared 510(k)s is 113 days.
What devices does Dalton Instrument Corp. make?
Its most frequent FDA product codes are IOR (Wheelchair, Mechanical, 2); CBR (Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.), 1); INO (Chair, Positioning, Electric, 1).
Has Dalton Instrument Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Dalton Instrument Corp. Related entities may recall under other names.
Next steps
- See all 5 Dalton Instrument Corp. clearances with predicates and recalls
- Run predicate analysis for product code IOR, Dalton Instrument Corp.'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.