Hill-Rom Services Pte, Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Hill-Rom Services Pte, Ltd.” (first 2013, latest 2020), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 118 days. Since 2017 the median was 106 days, against 214 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Baxter, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 118 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 268 |
| 2017 | 1 | 106 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 116 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hill-Rom Services Pte, Ltd. took a median 106 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 214 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHJ | Device, Positive Pressure Breathing, Intermittent | 4 | 4 |
| BYI | Percussor, Powered-Electric | 1 | 1 |
Review panels
- Anesthesiology (5)
Most recent Hill-Rom Services Pte, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200988 | Maximus System | NHJ | 2020-05-26 | 41 |
| K192143 | Maximus System | NHJ | 2020-02-14 | 190 |
| K163378 | Monarch Airway Clearance System | BYI | 2017-03-17 | 106 |
| K151689 | MetaNeb 4 System | NHJ | 2016-03-17 | 268 |
| K124032 | METANEB | NHJ | 2013-04-25 | 118 |
Recalls
openFDA lists no recalls under a recalling firm named Hill-Rom Services Pte, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Hill-Rom, Inc. (37 510(k)s)
- Hill-Rom Air-Shields (5 510(k)s)
- Hill-Rom Manufacturing, Inc. (4 510(k)s)
- Hill-Rom Holdings, Inc. (1 510(k)s)
- Hill-Rom Services Private Limited (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hill-Rom Services Pte, Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Hill-Rom Services Pte, Ltd.” (first 2013, latest 2020), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hill-Rom Services Pte, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hill-Rom Services Pte, Ltd. is 118 days. Since 2017: 106 days, versus 214 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hill-Rom Services Pte, Ltd.?
The most frequent FDA product codes under this applicant name are NHJ (Device, Positive Pressure Breathing, Intermittent, 4); BYI (Percussor, Powered-Electric, 1).
Next steps
- See all 5 Hill-Rom Services Pte, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NHJ, Hill-Rom Services Pte, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.