Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Inkspace Imaging, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
24 daysmedian FDA review time
81 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253182 | InkSpace Imaging Small Body Array (SBA12PH30x) | Inkspace Imaging, Inc. | 2025-10-20 | 24 | 0 |
| K243675 | InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. | 2024-12-20 | 23 | 0 |
| K233444 | InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. | 2024-01-08 | 81 | 0 |
| K223487 | InkSpace Imaging Body Array | Inkspace Imaging, Inc. | 2022-12-08 | 17 | 0 |
| K213397 | InkSpace Imaging Pediatric Body Array | Inkspace Imaging, Inc. | 2021-12-17 | 60 | 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