510(k) · Cleared
ClearedMamaLift Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curio Digital Therapeutics, Inc. · SAP Computerized Behavioral Therapy Device For Depressive Disorders.
Cleared on Apr 22, 2024 as substantially equivalent to K191716 (Pear Therapeutics, Inc., 2020) after a 517-day review. Its family tree reaches back 2 generations to 2017.
- Decided
- Apr 22, 2024
- Review
- 517 days
- Class
- Class II
- Product code
- SAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN160018 (2017). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SAP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new SAP device
- #1 K254038 Motivista (CT-155)score 12.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K191716 | SomrystSummary page 4…hiatric Disorders Product Code: SAP Product Code Name: Computerized behavioral therapy device for depressive disorders. Regulatory Class: II Predicate Device: Somryst™ (K191716) by Pear Therapeutics Inc., a cognitive behavioral therapy for insomnia (CBT‐I) via a mobile application). Trade/Device Name: Som… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K191716.
How does its category compare?
All SAP devicesSAP Computerized Behavioral Therapy Device For Depressive Disorders.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SAP
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · SAP
Too few SAP 510(k)s in any year since 2007 to give a median.
Recalls per year · SAP
No recall names SAP since 2007.
Adverse event reports per year · SAP
No MAUDE report names SAP since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
MamaLift Plus is a prescription-only digital therapeutic intended to provide neurobehavioral interventions to patients 22 years of age and older, as an adjunct to clinician-managed outpatient care. MamaLift Plus treats mild to moderate postpartum depression by improving a patient's symptoms of depression.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223515 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223515: MamaLift Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223515
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026