Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Iob Medical, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
201 daysmedian FDA review time
265 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232638 | FilteredFlo Warming Blankets | Iob Medical, Inc. | 2023-10-24 | 55 | 0 |
| K231596 | IOB Temperature Management System | Iob Medical, Inc. | 2023-06-30 | 29 | 0 |
| K221669 | IOB Warming Blankets | Iob Medical, Inc. | 2022-12-27 | 201 | 0 |
| K201896 | ivi N3003 Surgical face Mask, ivi N6006 Surgical mask | Iob Medical, Inc. | 2021-03-30 | 265 | 0 |
| K190221 | IOB Warming Blankets | Iob Medical, Inc. | 2019-10-25 | 262 | 0 |
| K162679 | IOB Temperature Management System | Iob Medical, Inc. | 2017-04-28 | 214 | 0 |
| K132668 | IOB DISPOSABLE SPECULUM | Iob Medical, Inc. | 2014-01-17 | 143 | 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