Hill-Rom, Inc.: FDA filings under this applicant name

FDA lists 37 510(k) clearances under the applicant name “Hill-Rom, Inc.” (first 1986, latest 2026), across 18 product codes in 7 review panels. Median 510(k) review time under this name: 179 days. Since 2017 the median was 202 days, against 152 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

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Hill-Rom, Inc. took a median 202 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 152 days.

Top product codes

Plus 8 more product codes.

Review panels

• General Hospital (15)
• Physical Medicine (13)
• Obstetrics and Gynecology (3)
• Anesthesiology (2)
• Cardiovascular (2)
• Gastroenterology and Urology (1)
• General and Plastic Surgery (1)

Most recent Hill-Rom, Inc. 510(k) clearances

27 earlier clearances. See the full list in Caduvo.

Recalls

96 product recalls in 64 recall events; 4 initiated in the last five years. Most recent: 2022-01-14.

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.

Device clinical trials

An industry sponsor named Hill-Rom, Inc. is the lead sponsor of 14 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT03628833: Incontinence Management System ICU Field Evaluation (Completed, started 2018-07-10)
• NCT03463434: AFT/CLP-LAL RCT Stage 3 or 4 Pressure Injuries (Completed, started 2018-05-10)
• NCT03091062: Evaluation of an Airway Clearance System (Completed, started 2017-03-30)
• NCT03797677: MN4000 for Treatment of CF and MND Patients in the Home Setting (Completed, started 2017-03-09)
• NCT02871258: MetaNeb® Chest X-ray Study (Completed, started 2016-09)

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 Air-Shields (5 510(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, Inc.?

FDA lists 37 510(k) clearances under the applicant name “Hill-Rom, Inc.” (first 1986, latest 2026), across 18 product codes in 7 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, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Hill-Rom, Inc. is 179 days. Since 2017: 202 days, versus 152 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Hill-Rom, Inc.?

The most frequent FDA product codes under this applicant name are IOQ (Bed, Flotation Therapy, Powered, 7); FNL (Bed, Ac-Powered Adjustable Hospital, 5); FMT (Warmer, Infant Radiant, 4).

Next steps

• See all 37 Hill-Rom, Inc. clearances with predicates and recalls
• Run predicate analysis for product code IOQ, Hill-Rom, Inc.'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.

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