Cleared Traditional

K223785 - N9+ (FDA 510(k) Clearance)

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

K223785 · Nonagon , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
119d
Days
Class 2
Risk

K223785 is an FDA 510(k) clearance for the N9+. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Nonagon , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on April 14, 2023 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - 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 Nonagon , Ltd. devices

Submission Details

510(k) Number K223785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2022
Decision Date April 14, 2023
Days to Decision 119 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
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQD Stethoscope, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1875
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 Consultant

Hogan Lovells US Lpp
Jonathan Kahan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQD Stethoscope, Electronic

All 152
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K223785.
Tyto Stethoscope (G3)
K252089 · Tyto Care , Ltd. · Mar 2026
Kneevoice Cartilage Evaluation System (750-3600-001)
K252076 · Kneevoice, Inc. · Feb 2026
eMurmur Heart AI
K252284 · Csd Labs · Dec 2025
Stethophone Pro
K252595 · Sparrow Acoustics, Inc. · Sep 2025
Eko Foundation Analysis Software with Transformers (EFAST)
K251494 · Eko Health, Inc. · Aug 2025
AccurSound Electronic Stethoscope (AS101)
K242971 · Heroic Faith International , Ltd. · Nov 2024