Cleared Traditional

K223515 - MamaLift Plus (FDA 510(k) Clearance)

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

K223515 · Curio Digital Therapeutics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
517d
Days
Class 2
Risk

K223515 is an FDA 510(k) clearance for the MamaLift Plus. Classified as Computerized Behavioral Therapy Device For Depressive Disorders. (product code SAP), Class II - Special Controls.

Submitted by Curio Digital Therapeutics, Inc. (Princeton, US). The FDA issued a Cleared decision on April 22, 2024 after a review of 517 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5801 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Curio Digital Therapeutics, Inc. devices

Submission Details

510(k) Number K223515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2022
Decision Date April 22, 2024
Days to Decision 517 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
369d slower than avg
Panel avg: 148d · This submission: 517d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SAP Computerized Behavioral Therapy Device For Depressive Disorders.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5801
Definition The Device Is Intended To Provide Computerized Behavioral Therapy To Treat Depressive Disorders.
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 Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03024645 Unknown Interventional

Be a Mom: Effectiveness of a Web-based Preventive Intervention for Postpartum Depression

Be a Mom: A Randomized Controlled Trial of the Effectiveness of a Web-based Preventive Intervention for Postpartum Depression.

1000
Patients (est.)
1
Site
Prevention
Purpose
Single blind
Masking
Condition studied PostPartum Depression
Study design Parallel
Eligibility Female only · 18 Years+
Principal investigator Ana Fonseca, PhD
Sponsor University of Coimbra
Started 2017-08-01 → Primary completion 2021-09-01 → Completed 2021-12-31
Primary outcome
Number of women with clinically significant postpartum depressive symptoms (EPDS > 12) at 4 months postpartum
Secondary outcome
Changes from baseline in anxiety symptoms
View full study on ClinicalTrials.gov