Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Imds Operations B.V. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
212 daysmedian FDA review time
258 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242337 | FlowGuide (FG60F); GuidionShort (GS60F) | Imds Operations B.V. | 2025-04-17 | 253 | 0 |
| K241611 | ShapeIT (SI014135) | Imds Operations B.V. | 2024-09-03 | 90 | 0 |
| K223728 | Micro Rx | Imds Operations B.V. | 2023-07-13 | 212 | 0 |
| K210431 | ReCross | Imds Operations B.V. | 2021-07-15 | 153 | 0 |
| K210110 | Guidion | Imds Operations B.V. | 2021-03-31 | 71 | 0 |
| K200324 | NHancer Rx | Imds Operations B.V. | 2020-08-06 | 178 | 0 |
| K191229 | TrapIt | Imds Operations B.V. | 2020-01-21 | 258 | 0 |
| K121077 | NHANCER | Imds Operations B.V. | 2012-12-21 | 256 | 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