Cleared Traditional

K212045 - SoftSpot (FDA 510(k) Clearance)

Class I Neurology device.

K212045 · Pediametrix, Inc. · Neurology device
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Sep 2021
Decision
90d
Days
Class 1
Risk

K212045 is an FDA 510(k) clearance for the SoftSpot. Classified as Cranial Measurement Software (product code QQO), Class I - General Controls.

Submitted by Pediametrix, Inc. (Rockville, US). The FDA issued a Cleared decision on September 28, 2021 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 878.4800 - 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 Pediametrix, Inc. devices

Submission Details

510(k) Number K212045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2021
Decision Date September 28, 2021
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QQO Cranial Measurement Software
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
Definition Cranial Measurement Software Is Intended To Be Used To Calculate And Display Physical Measurements Of The Head For Interpretation By A Qualified User In Conjunction With Other Clinical Methods.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.