Infinity CentralStation Wide— 510(k) K151860
Substantially EquivalentDraeger Medical Systems, Inc.
FDA 510(k) clearance K151860 for Infinity CentralStation Wide, Substantially Equivalent on 2015-09-02. Applicant: Draeger Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Draeger Medical Systems, Inc.
- Product code
- Code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Andover, MA, US
Recent devices under product code MHX
view allMore clearances from Draeger Medical Systems, Inc.
view allAdverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K151860
K-number listed on FDA's recall record- Z-1066-2025 — Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation.
- Z-1471-2023 — Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151860.
Data sourced from openFDA. This site is unofficial and independent of the FDA.