Chrysalis Intelligence · Product Codes · QNV

QNV · Adjunctive Hemodynamic Indicator With Decision Point

Cardiovascular · 3 clearances · 1 unique sponsors

Device class
Class II
Regulation 870.2220
Total clearances
3
2021-03-01 → 2022-07-14
Last 12 months
0
Unique sponsors
1
Definition

What is Adjunctive Hemodynamic Indicator With Decision Point

An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information.
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.2220
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
Fifth Eye, Inc. 3 0 2022-07-14
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 Electrocardiogram, routine ECG with at least 12 leads; interpretation and report only
99457 CPT Medium Remote monitoring of physiologic parameters; setup and patient education
99458 CPT Medium Remote monitoring of physiologic parameters; interpretation and management services per calendar month
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2022-07-14 K221203 Fifth Eye, Inc. AHI System
2021-12-03 K212219 Fifth Eye, Inc. AHI System
2021-03-01 DEN200022 Fifth Eye, Inc. Analytic for Hemodynamic Instability (AHI)