Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Human Xtensions , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
189 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223718 | HandX™ Self-Righting Needle Holder | Human Xtensions , Ltd. | 2023-06-05 | 175 | 0 |
| K230491 | HandX™ Monopolar Scissors | Human Xtensions , Ltd. | 2023-05-10 | 76 | 0 |
| K222011 | HandX Instrument - Monopolar Spatula | Human Xtensions , Ltd. | 2023-01-12 | 189 | 0 |
| K212214 | HandX | Human Xtensions , Ltd. | 2021-09-13 | 60 | 0 |
| K203603 | Monopolar Hook | Human Xtensions , Ltd. | 2021-02-01 | 54 | 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