Cleared Traditional

K230386 - SpassageQ (FDA 510(k) Clearance)

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

K230386 · Spass, Inc. · Cardiovascular device
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Jun 2023
Decision
121d
Days
Class 2
Risk

K230386 is an FDA 510(k) clearance for the SpassageQ. Classified as Multivariate Vital Signs Index (product code PLB), Class II - Special Controls.

Submitted by Spass, Inc. (Seoul, KR). The FDA issued a Cleared decision on June 15, 2023 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Spass, Inc. devices

Submission Details

510(k) Number K230386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2023
Decision Date June 15, 2023
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PLB Multivariate Vital Signs Index
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
Definition Automated Calculation Of A Summary Index (or Indices) Based On Several Individual Measured Vital Sign Inputs.
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

Radios, LLC
Edward Park

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.