Cleared Traditional

Clear Guide SCENERGY (K201188) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence.

K201188 · Clear Guide Medical · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2020
Decision
152d
Days
Class 2
Risk

K201188 is an FDA 510(k) clearance for the Clear Guide SCENERGY. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Clear Guide Medical (Baltimore, US). The FDA issued a Cleared decision on September 30, 2020 after a review of 152 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Clear Guide Medical devices

Submission Details

510(k) Number K201188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2020
Decision Date September 30, 2020
Days to Decision 152 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 107d · This submission: 152d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Radiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04031495 Completed Interventional Industry-sponsored

Image Guidance for Improved Vessel Cannulation in Pediatric Patients

4
Patients (actual)
1
Site
Device_feasibility
Purpose
Open label
Masking
Condition studied Central Vein Cannulation
Study design Single group
Eligibility All sexes · 2 Years+
Principal investigator Karun Sharma, MD
Sponsor Clear Guide Medical (industry)
Started 2019-04-22 → Primary completion 2019-05-10
Primary outcome
Successful Central Vein Cannulation
Study completed - no results published. This trial concluded in 2019 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 450
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K201188.
FastStroke, CT Perfusion 4D
K193289 · GE Medical Systems SCS · Nov 2020
LSN
K201092 · Imaging Biometrics, LLC · Oct 2020
syngo.CT Neuro Perfusion
K202213 · Siemens Medical Solutions USA, Inc. · Oct 2020
VIDAvision
K200990 · Vida Diagnostics, Inc. · Aug 2020
Clear Guide SCENERGY
K201898 · Clear Guide Medical · Jul 2020
SOMATOM On.site and On.scene
K193277 · Siemens Medical Solutions USA, Inc. · Jul 2020