Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hill-Rom Manufacturing, 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) |
|---|---|---|---|---|---|
| K080226 | NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAV | Hill-Rom Manufacturing, Inc. | 2008-04-09 | 71 | 0 |
| K032772 | MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEME | Hill-Rom Manufacturing, Inc. | 2003-10-08 | 30 | 0 |
| K031387 | ISOLETTE INFANT INCUBATOR, MODEL C2000E | Hill-Rom Manufacturing, Inc. | 2003-08-01 | 91 | 0 |
| K014094 | MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANA | Hill-Rom Manufacturing, Inc. | 2002-01-11 | 30 | 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