Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hygeia II Medical Group, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233136 | Hygeia Express Powered Breast Pump | Hygeia II Medical Group, Inc. | 2024-03-13 | 168 | 0 |
| K212955 | Fit Pro Breast Pump | Hygeia II Medical Group, Inc. | 2022-03-15 | 180 | 0 |
| K200406 | Evolve Breast Pump | Hygeia II Medical Group, Inc. | 2020-03-18 | 28 | 0 |
| K190465 | Evolve Breast Pump | Hygeia II Medical Group, Inc. | 2019-10-18 | 234 | 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