Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hill-Rom Services Pte, Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
118 daysmedian FDA review time
268 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200988 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020-05-26 | 41 | 9 |
| K192143 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020-02-14 | 190 | 7 |
| K163378 | Monarch Airway Clearance System | Hill-Rom Services Pte, Ltd. | 2017-03-17 | 106 | 0 |
| K151689 | MetaNeb 4 System | Hill-Rom Services Pte, Ltd. | 2016-03-17 | 268 | 0 |
| K124032 | METANEB | Hill-Rom Services Pte, Ltd. | 2013-04-25 | 118 | 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