Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Adherium (Nz), Ltd. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
195 daysmedian FDA review time
268 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222247 | Hailie Sensor NF0110 | Adherium (Nz), Ltd. | 2023-02-08 | 197 | 0 |
| K221994 | Hailie Sensor NF0107 & NF0108 | Adherium (Nz), Ltd. | 2022-10-04 | 90 | 0 |
| K220622 | Hailie Sensor NF0106 | Adherium (Nz), Ltd. | 2022-07-15 | 134 | 0 |
| K211233 | Hailie Sensor NF0109 | Adherium (Nz), Ltd. | 2021-08-18 | 117 | 0 |
| K182638 | Hailie Sensor | Adherium (Nz), Ltd. | 2019-06-19 | 268 | 0 |
| K182573 | Hailie Sensor | Adherium (Nz), Ltd. | 2019-06-07 | 262 | 0 |
| K181405 | Hailie Sensor | Adherium (Nz), Ltd. | 2018-12-10 | 195 | 0 |
| K180407 | Smartinhaler | Adherium (Nz), Ltd. | 2018-07-25 | 161 | 0 |
| K173310 | SmartTouch | Adherium (Nz), Ltd. | 2018-03-26 | 159 | 0 |
| K163485 | SmartTouch | Adherium (Nz), Ltd. | 2017-08-30 | 261 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda