510(k) Report

FDA applicant

Hill-Rom, Inc.

Batesville, IN37 decisions1986–202618 recalls

FDA records 37 decisions for Hill-Rom, Inc. (Batesville, IN) from 1986 to 2026: 37 510(k) clearances. Most are in product codes IOQ (Bed, Flotation Therapy, Powered) and FNL (Bed, Ac-Powered Adjustable Hospital). Its devices cite 24 predicates, 10 of them its own earlier devices. 18 recalls are linked to its devices.

FDA’s records also spell it “Hill-Rom”, “Hill-Rom Co.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Hill-Rom, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2011: 12013: 12015: 12018: 12021: 12026 (partial year): 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2025

2007: 52009: 22012: 22013: 12014: 12016: 12017: 12021: 12023: 12025: 1
2007high 5 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Hill-Rom, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hill-Rom, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • IOQBed, Flotation Therapy, Powered7decisions
  • FNLBed, Ac-Powered Adjustable Hospital5decisions
  • FMTWarmer, Infant Radiant4decisions
  • FPOStretcher, Wheeled4decisions
  • BZQMonitor, Breathing Frequency2decisions
  • KNCTable, Obstetric (And Accessories)2decisions

Also: IKZ (2), HDD (1), FOX (1), FSY (1), INX (1), IPT (1).

Whose devices does it build on?

Its devices cite 24 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 10 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K951001Flexicair ExlipseHill-Rom, Inc. · 19952cite it
  • K922352The Advance Series From Hill-RomHill-Rom, Inc. · 19922cite it
  • K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals…Hill-Rom, Inc. · 20181cites it
  • K971366IncuwarmerHill-Rom, Inc. · 19981cites it
  • K945729Dynamicaire (TM) Sleep Surface, Zoneair (TM) Sleep SurfaceHill-Rom, Inc. · 19951cites it
  • K962942TotalcareHill-Rom, Inc. · 19971cites it

What has FDA decided for it lately?

  • K260211Dashboard (P007000)Hill-Rom, Inc. · 2026
  • K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate…Hill-Rom, Inc. · 2021
  • K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals…Hill-Rom, Inc. · 2018
  • K143414Hill-Rom Wireless Connectivity ModuleHill-Rom · 2015
  • K122473Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2Hill-Rom · 20132 recalls
  • K112502Procedural Strecher with Intellidrive P8000Hill-Rom Co. · 2011
  • K013709Hill-Rom Primaview Monitor SystemHill-Rom, Inc. · 2001
  • K973705Contor Table SurfaceHill-Rom, Inc. · 1998

All 34 as Hill-Rom, Inc. →All 2 as Hill-Rom →The one decision as Hill-Rom Co. →

What has been recalled?

18 recalls linked to its devices; the latest:

  • K122473Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other…Feb 25, 2025Class II
  • K122473HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031…Oct 4, 2023Class II
  • K915779Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an…May 28, 2021Class II
  • K962942TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient…Feb 23, 2017Class II
  • K915779Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and…Jul 15, 2016Class II
  • K915779Affinity¿ Four Birthing Bed, Product Usage: Product is intended to be used as birthing…Jun 26, 2014Class II

Other applicant names beginning “Hill-Rom”

FDA records each applicant name separately; these may or may not be the same firm.

Hill Laboratories Co. 17Hill-Med, Inc. 10Hill-Rom Air-Shields 5Hill-Rom Services Pte, Ltd. 5Hill-Rom Manufacturing, Inc. 4Hill-Rom Holdings, Inc. 1Hill Engineering 1Hill, Farrer & Borrill 1Hill-Rom Services Private Limited 1Hill Top Research, Inc. 1