Inrange Systems, Inc.: FDA clearances and approvals
Inrange Systems, Inc. has 1 FDA 510(k) clearance (first 2015, latest 2015), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time: 31 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 31 |
| 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 |
|---|---|---|---|
| NZH | Medication Management System, Remote | 2 | 1 |
Review panels
- General Hospital (2)
Most recent Inrange Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150174 | EMMA | NZH | 2015-02-26 | 31 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN060002 | De Novo | Medication Management System, Remote | 2007-06-13 |
Recalls
openFDA lists no recalls under a recalling firm named Inrange Systems, Inc..
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 Inrange Systems, Inc. have?
Inrange Systems, Inc. has 1 FDA 510(k) clearance (first 2015, latest 2015), plus 1 De Novo decision, across 1 product code in 1 review panel.
How long does FDA take to clear Inrange Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Inrange Systems, Inc.'s cleared 510(k)s is 31 days.
What devices does Inrange Systems, Inc. make?
Its most frequent FDA product codes are NZH (Medication Management System, Remote, 2).
Has Inrange Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Inrange Systems, Inc. Related entities may recall under other names.
Next steps
- See all 1 Inrange Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NZH, Inrange Systems, Inc.'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.