Company ยท US
Hill-Rom, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2026. Name variants (Inc, Corp, punctuation) are merged.
37510(k) clearances (1 in 12 months)
96recalls (0 in 12 months)
15recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FNL | Bed, Ac-Powered Adjustable Hospital | 41 |
| FSA | Lift, Patient, Non-Ac-Powered | 26 |
| KNC | Table, Obstetric (And Accessories) | 13 |
| IOQ | Bed, Flotation Therapy, Powered | 9 |
| FPO | Stretcher, Wheeled | 5 |
| FMT | Warmer, Infant Radiant | 4 |
| HDD | Table, Obstetrical, Ac-Powered (And Accessories) | 3 |
| INX | Bed, Air Fluidized | 3 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 3 |
| BZQ | Monitor, Breathing Frequency | 2 |
| FMS | Bed, Pediatric Open Hospital | 2 |
| FNJ | Bed, Manual | 2 |
| IKZ | Bed, Patient Rotation, Powered | 2 |
| DWJ | System, Thermal Regulating | 1 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 1 |
| FIN | Tank, Holding, Dialysis | 1 |
| FOX | Stand, Infusion | 1 |
| FRJ | Chair, Geriatric | 1 |
| FSY | Light, Surgical, Ceiling Mounted | 1 |
| HMX | Cannula, Ophthalmic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 13, 2026 | K260211 | Dashboard (P007000) Hill-Rom, Inc. | MSX |
| Mar 4, 2021 | K202018 | Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring Sys Hill-Rom, Inc. | BZQ |
| May 7, 2018 | K180079 | Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System p Hill-Rom, Inc. | BZQ |
| Mar 10, 2015 | K143414 | Hill-Rom Wireless Connectivity Module Hill-Rom | IOQ |
| Jun 3, 2013 | K122473 | TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 Hill-Rom | IOQ |
| Sep 19, 2011 | K112502 | PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 Hill-Rom Co. | INK |
| Nov 16, 2001 | K013709 | HILL-ROM PRIMAVIEW MONITOR SYSTEM Hill-Rom, Inc. | FET |
| Aug 7, 1998 | K973705 | CONTOR TABLE SURFACE Hill-Rom, Inc. | DWJ |
| Apr 29, 1998 | K981081 | BRIGHTSTAR Hill-Rom, Inc. | FSY |
| Feb 2, 1998 | K972111 | RUMORS DYNAMIC AIR THERAPY UNIT Hill-Rom, Inc. | IKZ |
| Jan 5, 1998 | K971366 | INCUWARMER Hill-Rom, Inc. | FMT |
| Aug 26, 1997 | K970636 | TOTALCARE., MODULAR THERAPY SYSTEM (MTS) Hill-Rom, Inc. | IOQ |
| Jul 3, 1997 | K964873 | SILKAIR LOW AIRLOSS THERAPY Hill-Rom, Inc. | IOQ |
| May 28, 1997 | K964223 | CLINITRON RITE-HITE Hill-Rom, Inc. | INX |
| May 16, 1997 | K970295 | FLEXICAIR EXLIPSE PLUS Hill-Rom, Inc. | IOQ |
| Apr 3, 1997 | K970074 | STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D) Hill-Rom, Inc. | FMT |
| Feb 3, 1997 | K962942 | TOTALCARE Hill-Rom, Inc. | FNL |
| Jan 9, 1997 | K963091 | VOLLMAN PRONE POSITIONER Hill-Rom, Inc. | IPT |
| Jun 3, 1996 | K961437 | WHEELED STRETCHER Hill-Rom, Inc. | FPO |
| Nov 22, 1995 | K952447 | HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER Hill-Rom, Inc. | FPO |
| Jun 27, 1995 | K951001 | FLEXICAIR EXLIPSE Hill-Rom, Inc. | IOQ |
| May 30, 1995 | K950756 | PULMONEX DYNAMIC AIR THERAPY UNIT Hill-Rom, Inc. | IKZ |
| Mar 17, 1995 | K944580 | FLEXSYS MOBILEMATE EQUIPMENT STAND Hill-Rom, Inc. | FOX |
| Feb 27, 1995 | K945729 | DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE Hill-Rom, Inc. | IOQ |
| Sep 16, 1994 | K942904 | STABILET Hill-Rom, Inc. | FMT |
| Dec 10, 1993 | K924420 | MEDICAL DISPOSABLE BEDDING Hill-Rom, Inc. | KNC |
| Jul 27, 1993 | K926140 | VACUUM POWER BODY FLUID SUCTION APPARATUS Hill-Rom, Inc. | KDP |
| Mar 31, 1993 | K922809 | GENERAL PROCEDURAL STRETCHERS (P880- P886) Hill-Rom, Inc. | FPO |
| Mar 31, 1993 | K922808 | HILL-ROM VIA STRETCHER (P1300 - P1303) Hill-Rom, Inc. | FPO |
| Feb 24, 1993 | K915779 | AFFINITY BED MODEL 3600 SERIES Hill-Rom, Inc. | KNC |
| Oct 13, 1992 | K922352 | THE ADVANCE SERIES FROM HILL-ROM Hill-Rom, Inc. | FNL |
| Jun 11, 1992 | K915437 | CRITICAL CARE HOSPITAL BED (ICU/CCU) Hill-Rom, Inc. | FNL |
| Apr 20, 1992 | K921528 | HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM Hill-Rom, Inc. | IQA |
| Apr 20, 1992 | K914309 | THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIES Hill-Rom, Inc. | HDD |
| Feb 12, 1992 | K913945 | STABILET INFANT RADIANT WARMER MODEL 2000C Hill-Rom, Inc. | FMT |
| Nov 13, 1986 | K864186 | HILL-ROM CENTURY CC MODELS 892 &894 (RADIOLUCENT) Hill-Rom, Inc. | FNL |
| Nov 13, 1986 | K864172 | HILL-ROM CENTURY CC, MODELS 891 & 893 WEIGHING SYS Hill-Rom, Inc. | FNL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2022 | Hill-Rom, Inc. (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift,
(2)Traverse Rail Carrier 31025XX component to Liko overhead lift.
Intended for to make safe lifting of a patient po Terminated |
FSA | None listed |
| Dec 23, 2021 | Hill-Rom, Inc. Liko Mobile Lifts: Primarily intended for use in nursing homes
LikoM230 Model: 2050015 Open, Classified |
FSA | None listed |
| Dec 23, 2021 | Hill-Rom, Inc. Liko Mobile Lifts: Primarily intended for use in nursing homes
Liko M220, Model 2050010 Open, Classified |
FSA | None listed |
| Oct 14, 2021 | Hill-Rom Inc. These are communication systems, labeled as:
a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9
b. Voalte Nurse Call, Part Number 4.0
*Product was rebranded from NaviCare to Voalte in 2020 Terminated |
ILQ | None listed |
| Aug 11, 2021 | Hill-Rom, Inc. LikoStretch Mod 600 IC Model Number: 3156065
LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The combination of this products allows the user to easily adjust/control Open, Classified |
FSA | None listed |
| Aug 11, 2021 | Hill-Rom, Inc. LikoStretch 1900 Model Number: 3156051 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. Open, Classified |
FSA | None listed |
| Aug 11, 2021 | Hill-Rom, Inc. Stretch Leveller Model Number: 3156200 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. Open, Classified |
FSA | None listed |
| Aug 11, 2021 | Hill-Rom, Inc. FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. Open, Classified |
FSA | None listed |
| Aug 11, 2021 | Hill-Rom, Inc. OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
Model Number: 3156056 Open, Classified |
FSA | None listed |
| May 28, 2021 | Hill-Rom, Inc. Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Lab Terminated |
KNC | K915779 |
| Jan 29, 2021 | Hill-Rom, Inc. Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the intended use in healthcare, intensive care and rehabilitation.
Affected devices:
Liko Multirall 200 (product number Terminated |
FSA | None listed |
| Jun 30, 2020 | Hill-Rom, Inc. Centrella Smart+ Bed, Catalog No. P7900 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or fo Terminated |
FNL | None listed |
| Jun 30, 2020 | Hill-Rom, Inc. Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any o Terminated |
FNL | None listed |
| Apr 30, 2020 | Hill-Rom, Inc. Centrella Smart+ Bed, Catalog Number P7900 Terminated |
FNL | None listed |
| Feb 14, 2020 | Hill-Rom Inc. NaviCare Patient Safety Software Versions 3.5.400-3.9.300.
The NaviCare Patient Safety (Patient Safety) Software is compatible with the following beds:
1. VersaCare
Revision A-J with upgrade kit
Terminated |
KMI | None listed |
| Jan 12, 2018 | Hill-Rom, Inc. Progressa Bed - AC-powered adjustable hospital bed Terminated |
FNL | None listed |
| Feb 23, 2017 | Hill-Rom, Inc. TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Numbers P1947A and P1948A). Terminated |
FNL | K962942 |
| Oct 31, 2016 | Hill-Rom, Inc. Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling
installed rail systems: Multirall 200, Likorall 200, 242, 243, 250,
and LikoGuard L and XL. Terminated |
FSA | None listed |
| Sep 8, 2016 | Hill-Rom, Inc. Affinity Four Birthing Bed Model P3700
The primary packaging is pictured below, and utilizes a metal packing brace, standard corrugated cardboard and plastic banding. When possible these beds are s Terminated |
KNC | K915779 |
| Aug 9, 2016 | Hill-Rom, Inc. Volker 2080, 2082, S 280 and S 282 series beds with lateral release button.
A/C Powered Adjustable Hospital Bed
Product Usage:
Volker model 2080/3010/3080 nursing beds are intended for the care of re Terminated |
FNL | None listed |
| Jun 7, 2016 | Hill-Rom, Inc. Liko Universal SlingBars
Universal SlingBar" 350,
Universal SlingBar" 350 QRH,
Universal SlingBar" 350 R2R,
Universal SlingBar" 450,
Universal SlingBar" 450 QRH,
Universal SlingBar" 450 R2R,
Un Terminated |
FSA | None listed |
| Feb 23, 2016 | Hill-Rom, Inc. Hill-Rom Bariatric Power Recliner, Product Model # P9096
Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience f Terminated |
FRJ | None listed |
| Nov 13, 2015 | Hill-Rom, Inc. Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed Terminated |
FNL | None listed |
| Jun 19, 2015 | Hill-Rom, Inc. Viking M, L, and XL Mobile Lifts.
Non-AC-powered patient lift. Terminated |
FSA | None listed |
| Jun 19, 2015 | Hill-Rom, Inc. Steriseal-Cannula Ophthalmic;
Bi-Manual Irrigating/Aspirating Handpiece. Terminated |
HMX | None listed |
| Sep 1, 2014 | Hill-Rom, Inc. Affinity Four Birthing Bed,
Product Usage:
Product is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Po Terminated |
KNC | K915779 |
| Jul 23, 2013 | Hill-Rom, Inc. TotalCare Bed used with AccuMax Quantum VPC mattress
AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress
The TotalCare Bed System is intended to provide a patient support idea Terminated |
IOQ | None listed |
| Jun 5, 2013 | Hill-Rom, Inc. Hill-Rom 1000 Bed, Product No. P1160. The Hill-Rom 1000 Bed is intended for low to moderate acuity patient in the medical surgical area of the hospital. Terminated |
FNL | None listed |
| Jun 5, 2013 | Hill-Rom, Inc. SlingBar Standard.
Designed to meet the needs for lifting humans. Terminated |
FSA | None listed |
| Jun 5, 2013 | Hill-Rom, Inc. SlingBar Wide 670.
Designed to meet the needs for lifting humans. Terminated |
FSA | None listed |
| Jun 5, 2013 | Hill-Rom, Inc. SlingBar 360.
Designed to meet the needs for lifting humans. Terminated |
FSA | None listed |
| Jun 5, 2013 | Hill-Rom, Inc. SlingBar 350.
Designed to meet the needs for lifting humans. Terminated |
FSA | None listed |
| Mar 14, 2013 | Hill-Rom, Inc. TotalCare SpO2RT2 bed.
Product Usage:
Bed, flotation therapy, powered bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progres Terminated |
IOQ | K970636 |
| Feb 21, 2013 | Hill-Rom, Inc. Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall, Multirall and Masterlift Systems
Product Usage - The Overhead Rail System allows overhead li Terminated |
FSA | None listed |
| Dec 31, 2012 | Hill-Rom, Inc. Liko Standard Slingbar 450.
The Standard Slingbar 450 is a versatile sling bar which can be used for most lifting situations. It can be used with different Liko ceiling and mobile lifts. Terminated |
FSA | None listed |
| Jul 26, 2012 | Hill-Rom, Inc. Affinity Four Birthing Bed P3700
Product Usage:
The Affinity, Four Birthing Bed is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery ) or LDRP Terminated |
KNC | None listed |
| Jun 22, 2012 | Hill-Rom, Inc. Advanta 2 Bed.
The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital. Terminated |
FNL | None listed |
| Mar 1, 2012 | Hill-Rom, Inc. Clinitron Rite Hite Bed headboard and foot side rails.
The Clinitron Rite Hite Air Fluidized Therapy Unit is a patient management system that combines air fluidized therapy and low airloss therapy te Terminated |
INX | K964223 |
| Mar 1, 2012 | Hill-Rom, Inc. Clinitron At Home Bed headboard and foot side rails.
The Clinitron At Home Air Fluidized Therapy Unit provides a pressure-relieving sleep surface for patients in the home environment. It helps enable Terminated |
INX | K964223 |
| Mar 17, 2011 | Hill-Rom, Inc. Liko Capella 201 Lift, Liko, Sweeden.
The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used wit Terminated |
FSA | None listed |
| Mar 17, 2011 | Hill-Rom, Inc. Liko Sabina 200 Lift, Liko, Sweeden.
The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with Terminated |
FSA | None listed |
| Mar 17, 2011 | Hill-Rom, Inc. Liko Sabina Comfort Lift, Liko, Sweeden.
The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used Terminated |
FSA | None listed |
| Mar 17, 2011 | Hill-Rom, Inc. Liko Sabina II EM Lift, Liko, Sweeden.
The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used wit Terminated |
FSA | None listed |
| Mar 17, 2011 | Hill-Rom, Inc. Liko Sabina EM Lift, Liko, Sweeden.
The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with Terminated |
FSA | None listed |
| Mar 17, 2011 | Hill-Rom, Inc. Liko Sabina II EE Lift, Liko, Sweeden.
The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used wi Terminated |
FSA | None listed |
| Mar 17, 2011 | Hill-Rom, Inc. Liko Sabina EE Lift, Liko, Sweeden.
The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with Terminated |
FSA | None listed |
| Mar 7, 2011 | Hill-Rom, Inc. VersaCare P500 Microclimate Management Surface Upgrade Kits P3218A and P3219A Hill-rom Batesville, IN.
The TotalCare Bed Systems is intended to provide a patient support ideally suited to be used in Terminated |
FNL | None listed |
| Mar 7, 2011 | Hill-Rom, Inc. VersaCare beds P3200 and P3201 with P500 Microclimate Management Surface Hill Rom, Batesville, IN.
The VersaCare Bed System is intended to provide a patient support suited to be used in healthcare e Terminated |
FNL | None listed |
| Mar 7, 2011 | Hill-Rom, Inc. TotalCare beds P1900 with P500 Microclimate Management Surface Hill Rom, Batesville, IN.
The TotalCare Bed Systems is intended to provide a patient support ideally suited to be used in health care en Terminated |
FNL | None listed |
| Feb 23, 2011 | Hill-Rom, Inc. Liko Comfort Sling Plus Model 300, Part number 35300305, Size Medium, LIKO, Sweden. Liko a Hill-Rom Company.
Enables a comfortable sitting position and adapts to the patient without the need for indi Terminated |
FSA | None listed |
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