Adherium (Nz), Ltd.: FDA clearances and approvals
Adherium (Nz), Ltd. has 10 FDA 510(k) clearances (first 2017, latest 2023), across 1 product code in 1 review panel. Median 510(k) review time: 178 days. Since 2017 its median was 178 days, against 236 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 261 |
| 2018 | 3 | 161 |
| 2019 | 2 | 265 |
| 2020 | 0 | — |
| 2021 | 1 | 117 |
| 2022 | 2 | 112 |
| 2023 | 1 | 197 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Adherium (Nz), Ltd.'s cleared 510(k)s took a median 178 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 236 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 10 | 10 |
Review panels
- Anesthesiology (10)
Most recent Adherium (Nz), Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222247 | Hailie Sensor NF0110 | CAF | 2023-02-08 | 197 |
| K221994 | Hailie Sensor NF0107 & NF0108 | CAF | 2022-10-04 | 90 |
| K220622 | Hailie Sensor NF0106 | CAF | 2022-07-15 | 134 |
| K211233 | Hailie Sensor NF0109 | CAF | 2021-08-18 | 117 |
| K182638 | Hailie Sensor | CAF | 2019-06-19 | 268 |
| K182573 | Hailie Sensor | CAF | 2019-06-07 | 262 |
| K181405 | Hailie Sensor | CAF | 2018-12-10 | 195 |
| K180407 | Smartinhaler | CAF | 2018-07-25 | 161 |
| K173310 | SmartTouch | CAF | 2018-03-26 | 159 |
| K163485 | SmartTouch | CAF | 2017-08-30 | 261 |
Recalls
openFDA lists no recalls under a recalling firm named Adherium (Nz), 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Adherium (Nz), Ltd.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Adherium (Nz), Ltd. have?
Adherium (Nz), Ltd. has 10 FDA 510(k) clearances (first 2017, latest 2023), across 1 product code in 1 review panel.
How long does FDA take to clear Adherium (Nz), Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Adherium (Nz), Ltd.'s cleared 510(k)s is 178 days. Since 2017: 178 days, versus 236 days for all cleared 510(k)s in the same product codes.
What devices does Adherium (Nz), Ltd. make?
Its most frequent FDA product codes are CAF (Nebulizer (Direct Patient Interface), 10).
Has Adherium (Nz), Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Adherium (Nz), Ltd. Related entities may recall under other names.
Next steps
- See all 10 Adherium (Nz), Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Adherium (Nz), 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.