Cleared Traditional

K212045 - SoftSpot

K212045 is an FDA 510(k) clearance for SoftSpot, manufactured by Pediametrix, Inc.. The device is a Class 1 Neurology device with product code QQO cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K212045

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.

QQO Device Classification - Class 1, General Controls

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.