Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PZR — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
134 daysmedian FDA review time
245 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251246 | Sparrow Ascent | Spark Biomedical, Inc. | 2025-08-25 | 125 | 0 |
| K233166 | NET Recovery Corp/NET Device | Net Recovery | 2024-05-29 | 245 | 0 |
| K230796 | Sparrow Ascent | Spark Biomedical, Inc. | 2023-06-20 | 90 | 1 |
| K221231 | Drug Relief v1 | Dyansys, Inc. | 2022-06-06 | 38 | 0 |
| K211971 | Drug Relief v1 | Dyansys, Inc. | 2021-11-05 | 134 | 0 |
| K201873 | Sparrow Therapy System | Spark Biomedical, Inc. | 2021-01-02 | 179 | 0 |
| K173861 | Drug Relief | Dyansys, Inc. | 2018-05-02 | 133 | 0 |
| DEN170018 | NSS-2 System | Innovative Health Solutions (Ihs), Inc. | 2017-11-15 | 243 | 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