Chrysalis Intelligence · Product Codes · QAQ

QAQ · Adjunctive Predictive Cardiovascular Indicator

Cardiovascular · 3 clearances · 1 unique sponsors

Device class
Class II
Regulation 870.2210
Total clearances
3
2021-07-30 → 2025-05-15
Last 12 months
0
Unique sponsors
1
Definition

What is Adjunctive Predictive Cardiovascular Indicator

The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.2210
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Edwards Lifesciences, LLC 3 0 2025-05-15
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
93000 CPT Medium CPT for electrocardiogram with analysis and interpretation
99457 CPT Medium CPT for remote monitoring of cardiovascular device or vital signs
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-05-15 K242518 Edwards Lifesciences, LLC Hypertension Prediction Index (HePI) Algorithm
2023-06-08 K230057 Edwards Lifesciences, LLC Acumen Hypotension Prediction Index (HPI) Algorithm
2021-07-30 K203224 Edwards Lifesciences, LLC Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform