Cleared Traditional

K230842 - SignalHF (IM008) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230842 · Implicity, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
211d
Days
Class 2
Risk

K230842 is an FDA 510(k) clearance for the SignalHF (IM008). Classified as Medium-term Adjunctive Predictive Cardiovascular Indicator (product code QNL), Class II - Special Controls.

Submitted by Implicity, Inc. (Cambridge, US). The FDA issued a Cleared decision on October 25, 2023 after a review of 211 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2210 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Implicity, Inc. devices

Submission Details

510(k) Number K230842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2023
Decision Date October 25, 2023
Days to Decision 211 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 125d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QNL Medium-term Adjunctive Predictive Cardiovascular Indicator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2210
Definition 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 Within A Defined Medium-term Period. This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - QNL Medium-term Adjunctive Predictive Cardiovascular Indicator

Devices cleared under the same product code (QNL) and FDA review panel - the closest regulatory comparables to K230842.
eCARTv5 Clinical Deterioration Suite (“eCART”)
K233253 · Agilemd, Inc. · Jun 2024
CLEWICU System
K233216 · Clew Medical , Ltd. · Jan 2024
Global Hypoperfusion Index (GHI) Algorithm
K231038 · Edwards Lifesciences, LLC · Jul 2023
CLEWICU System (ClewICUServer and ClewICUnitor)
K200717 · Clew Medical , Ltd. · Jan 2021