Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Subtle Medical, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
122 daysmedian FDA review time
164 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254120 | SubtleHD-CT (1.x) | Subtle Medical, Inc. | 2026-05-15 | 147 | 0 |
| K254013 | SubtleHD-PET (1.x) | Subtle Medical, Inc. | 2026-05-14 | 150 | 0 |
| K243250 | SubtleHD (1.x) | Subtle Medical, Inc. | 2025-02-12 | 120 | 0 |
| K240290 | AiMIFY (1.x) | Subtle Medical, Inc. | 2024-08-21 | 202 | 0 |
| K241329 | SubtleSYNTH (1.x) | Subtle Medical, Inc. | 2024-07-11 | 62 | 0 |
| K233699 | SubtleREFORMAT (1.x) | Subtle Medical, Inc. | 2024-04-29 | 164 | 0 |
| K223623 | SubtleMR (2.3.x) | Subtle Medical, Inc. | 2023-05-11 | 157 | 0 |
| K211964 | SubtlePET | Subtle Medical, Inc. | 2021-09-28 | 96 | 0 |
| K203182 | SubtleMR | Subtle Medical, Inc. | 2021-02-26 | 122 | 0 |
| K191688 | SubtleMR | Subtle Medical, Inc. | 2019-09-16 | 84 | 0 |
| K182336 | SubtlePET | Subtle Medical, Inc. | 2018-11-30 | 94 | 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