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FDA 510(k)

LifeOutcomes C-Quest™ Blood Culture Sampling Device

K-Number: K231282 · 2024-01-26

ApplicantLifeoutcomes, LLC
Decision Date2024-01-26
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LifeOutcomes C-Quest™ Blood Culture Sampling Device is a medical device manufactured by Lifeoutcomes, LLC. It received FDA 510(k) clearance on 2024-01-26 under approval number K231282. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LifeOutcomes C-Quest™ Blood Culture Sampling Device?

LifeOutcomes C-Quest™ Blood Culture Sampling Device is a medical device that received FDA 510(k) clearance on 2024-01-26. It is manufactured by Lifeoutcomes, LLC. The 510(k) number is K231282.

When was LifeOutcomes C-Quest™ Blood Culture Sampling Device approved by the FDA?

LifeOutcomes C-Quest™ Blood Culture Sampling Device received FDA 510(k) clearance on 2024-01-26, under approval number K231282.

What company makes LifeOutcomes C-Quest™ Blood Culture Sampling Device?

LifeOutcomes C-Quest™ Blood Culture Sampling Device is manufactured by Lifeoutcomes, LLC.

What is the FDA product code for LifeOutcomes C-Quest™ Blood Culture Sampling Device?

The FDA product code for LifeOutcomes C-Quest™ Blood Culture Sampling Device is JKA.

Related Clinical Trials

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Related Devices (Code: JKA)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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