Capsule Technologie: FDA clearances and approvals
Capsule Technologie has 5 FDA 510(k) clearances (first 2001, latest 2019), across 1 product code in 1 review panel. Median 510(k) review time: 102 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 141 |
| 2019 | 1 | 112 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Capsule Technologie's cleared 510(k)s took a median 126 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 217 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 5 | 5 |
Review panels
- Cardiovascular (5)
Most recent Capsule Technologie 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K183638 | SmartLinx Vitals Plus Patient Monitoring System | MWI | 2019-04-17 | 112 |
| K180734 | SmartLinx Vitals Plus Patient Monitoring System | MWI | 2018-08-08 | 141 |
| K032142 | DATACAPTOR | MWI | 2003-08-08 | 25 |
| K020197 | MODIFICATION TO DATACAPTOR | MWI | 2002-02-21 | 30 |
| K013019 | DATACAPTOR | MWI | 2001-12-18 | 102 |
Recalls
openFDA lists no recalls under a recalling firm named Capsule Technologie.
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 Capsule Technologie have?
Capsule Technologie has 5 FDA 510(k) clearances (first 2001, latest 2019), across 1 product code in 1 review panel.
How long does FDA take to clear Capsule Technologie's 510(k)s?
The median time from FDA receipt to decision across Capsule Technologie's cleared 510(k)s is 102 days.
What devices does Capsule Technologie make?
Its most frequent FDA product codes are MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 5).
Has Capsule Technologie had device recalls?
openFDA lists no recalls under a recalling firm name matching Capsule Technologie. Related entities may recall under other names.
Next steps
- See all 5 Capsule Technologie clearances with predicates and recalls
- Run predicate analysis for product code MWI, Capsule Technologie'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.