FloTrac sensors +3 more models
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242909 FDA 510(k)
- FDA Product Code
- DRS FDA 510(k)
- Models / Variants
- FloTrac sensors FDA 510(k)FloTrac Jr sensors FDA 510(k)Acumen IQ sensors FDA 510(k)VolumeView sensors FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2850 FDA 510(k)
- Regulation Number
- 870.2850 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
These are extravascular blood pressure transducers and advanced hemodynamic monitoring sensors designed for continuous, minimally-invasive measurement of key flow parameters. The devices automatically calculate hemodynamic values every 20 seconds and, in the case of the Acumen IQ sensor, work with Acumen Hypotension Prediction Index (HPI) software to provide insight into the root cause of hypotensive events by assessing preload, afterload, and contractility.
The sensors are supplied by Edwards Lifesciences, LLC, and are intended for use in cardiovascular settings as classified under the FDA product code DRS and regulation 21 CFR 870.2850. They are listed as Class II devices and were reviewed under the Cardiovascular advisory committee. The regulatory submission was filed under FDA 510(k) with a substantially equivalent decision.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView ..., Acumen IQ sensor | Edwards Lifesciences, FloTrac Sensor | Edwards Lifesciences
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242909 | Class II | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA 510(k) K242909 24 fields · synced Oct 6, 2026