Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation
FDA 510(k) K180079 · Hill-Rom, Inc.
510(k) numberK180079
Submission
- Device name
- Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation
- Applicant
- Hill-Rom, Inc.
Batesville, IN, US - Received
- January 10, 2018
- Decision date
- May 7, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZQ – Monitor, Breathing Frequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
Other 510(k)s with product code BZQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253274 | BedDot (G1)BZQ · Traditional | Intelligent Dots, LLC | 06/25/2026SE |
| K251326 | Respiration Rate algorithmBZQ · Traditional | Edwards Lifesciences, LLC | 06/11/2026SE |
| K250093 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)BZQ · Traditional | Linshom Medical, Inc. | 09/26/2025SE |
| K250934 | Respiree Cardio- Respiratory Monitor SystemBZQ · Traditional | Respiree Pte, Ltd. | 08/05/2025SE |
| K243183 | RTMsense Respiratory Monitoring SystemBZQ · Traditional | Rtm Vital Signs, LLC | 06/27/2025SE |
| K243966 | FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)BZQ · Traditional | Faceheart Corp. | 04/09/2025SE |
| K242001 | Philips VSC-MEDlibBZQ · Traditional | Philips Medical Systems Nederland B.V. | 04/04/2025SE |
| K233953 | Makani Science Respiration Monitoring SystemBZQ · Traditional | Makani Science, Inc. | 03/28/2025SE |
| K242798 | AirmodBZQ · Traditional | Heroic Faith International , Ltd. | 02/28/2025SE |
| K240271 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)BZQ · Traditional | Linshom Medical, Inc. | 09/11/2024SE |
More from Linshom Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260211 | Dashboard (P007000)MSX · Traditional | 08/13/2026SE |
| K202018 | Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and…BZQ · Traditional | 03/04/2021SE |
| K143414 | Hill-Rom Wireless Connectivity ModuleIOQ · Traditional | 03/10/2015SE |
| K122473 | Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2IOQ · Traditional | 06/03/2013SE |
| K112502 | Procedural Strecher with Intellidrive P8000INK · Traditional | 09/19/2011SE |
| K013709 | Hill-Rom Primaview Monitor SystemFET · Traditional | 11/16/2001SE |
| K973705 | Contor Table SurfaceDWJ · Traditional | 08/07/1998SE |
| K981081 | BrightstarFSY · Traditional | 04/29/1998SE |
| K972111 | Rumors Dynamic Air Therapy UnitIKZ · Traditional | 02/02/1998SE |
| K971366 | IncuwarmerFMT · Traditional | 01/05/1998SE |
Questions and answers
When was Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation cleared by the FDA?
Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation (K180079) received a 510(k) decision of Substantially Equivalent on May 7, 2018, 117 days after the submission was received.
What is the product code of K180079?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.