Hill-Rom Air-Shields: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Hill-Rom Air-Shields” (first 2000, latest 2003), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 86 days. 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 Drägerwerk, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMZ | Incubator, Neonatal | 2 | 2 |
| FMT | Warmer, Infant Radiant | 1 | 1 |
| FPL | Incubator, Neonatal Transport | 1 | 1 |
| MQM | Bilirubin (Total And Unbound) In The Neonate Test System | 1 | 1 |
Review panels
Most recent Hill-Rom Air-Shields 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021622 | HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 | MQM | 2003-04-01 | 320 |
| K003335 | RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER | FMT | 2000-11-17 | 23 |
| K001242 | ISOLETTE INFANT INCUBATOR, MODEL C2HS | FMZ | 2000-07-13 | 86 |
| K001019 | TI500 GLOBE-TROTTER TRANSPORT SYSTEM | FPL | 2000-04-27 | 28 |
| K993051 | VERSALET 7700 CARE CENTER, MODEL # 7700 | FMZ | 2000-02-03 | 143 |
Recalls
openFDA lists no recalls under a recalling firm named Hill-Rom Air-Shields.
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 Services Pte, Ltd. (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 Air-Shields?
FDA lists 5 510(k) clearances under the applicant name “Hill-Rom Air-Shields” (first 2000, latest 2003), across 4 product codes in 2 review panels. 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 Air-Shields?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hill-Rom Air-Shields is 86 days.
Which FDA product codes appear under Hill-Rom Air-Shields?
The most frequent FDA product codes under this applicant name are FMZ (Incubator, Neonatal, 2); FMT (Warmer, Infant Radiant, 1); FPL (Incubator, Neonatal Transport, 1).
Next steps
- See all 5 Hill-Rom Air-Shields clearances with predicates and recalls
- Run predicate analysis for product code FMZ, Hill-Rom Air-Shields'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.