Cleared Traditional

K221257 - SpectraWAVE Imaging System

K221257 is an FDA 510(k) clearance for SpectraWAVE Imaging System, manufactured by Spectrawave, Inc.. The device is a Class 2 Cardiovascular device with product code NQQ cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K221257 · Spectrawave, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 2023
Decision
302d
Days
Class 2
Risk

K221257 is an FDA 510(k) clearance for the SpectraWAVE Imaging System. Classified as System, Imaging, Optical Coherence Tomography (oct) (product code NQQ), Class II - Special Controls.

Submitted by Spectrawave, Inc. (Bedford, US). The FDA issued a Cleared decision on February 28, 2023 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 892.1560 - 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. Elevated predicate reliance profile. 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 Spectrawave, Inc. devices

FDA 510(k) Submission Details - K221257

510(k) Number K221257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2022
Decision Date February 28, 2023
Days to Decision 302 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
177d slower than avg
Panel avg: 125d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NQQ Device Classification - Class 2, Special Controls

Product Code NQQ System, Imaging, Optical Coherence Tomography (oct)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
Definition This Device Uses Back-reflected Light To Create Two-dimensional Images Versus Back-reflected Sound Waves As Are Used In Ultrasound Imaging.
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 - NQQ System, Imaging, Optical Coherence Tomography (oct)

All 24
Devices cleared under the same product code (NQQ) and FDA review panel - the closest regulatory comparables to K221257.
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