Cleared Traditional

K180568 - KidCap

K180568 is an FDA 510(k) clearance for KidCap, manufactured by Eastern Cranial Affiliates, LLC. The device is a Class 2 Neurology device with product code MVA cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K180568 · Eastern Cranial Affiliates, LLC · Neurology device
Download Printable Device Report (PDF)
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Oct 2018
Decision
225d
Days
Class 2
Risk

K180568 is an FDA 510(k) clearance for the KidCap. Classified as Orthosis, Cranial (product code MVA), Class II - Special Controls.

Submitted by Eastern Cranial Affiliates, LLC (Fairfax, US). The FDA issued a Cleared decision on October 16, 2018 after a review of 225 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5970 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Eastern Cranial Affiliates, LLC devices

FDA 510(k) Submission Details - K180568

510(k) Number K180568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2018
Decision Date October 16, 2018
Days to Decision 225 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 149d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MVA Device Classification - Class 2, Special Controls

Product Code MVA Orthosis, Cranial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5970
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 Neurology devices follow this clearance model.

Regulatory Peers - MVA Orthosis, Cranial

All 41
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