Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Guard Medical, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
30 daysmedian FDA review time
146 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251156 | NPseal | Guard Medical, Inc. | 2025-05-15 | 30 | 0 |
| K250708 | NPseal | Guard Medical, Inc. | 2025-04-08 | 29 | 0 |
| K241522 | NPseal (20 and 25) | Guard Medical, Inc. | 2024-08-15 | 78 | 0 |
| K240244 | NPseal (Small, Medium, Large) | Guard Medical, Inc. | 2024-02-29 | 30 | 0 |
| K212971 | NPseal | Guard Medical, Inc. | 2022-02-10 | 146 | 0 |
| K211130 | NPseal | Guard Medical, Inc. | 2021-05-14 | 28 | 0 |
| K200305 | NPseal | Guard Medical, Inc. | 2020-05-26 | 110 | 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