510(k) · Cleared
ClearedLuma Wrap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Salter Labs · PDH Blanket, Neonatal Phototherapy
Cleared on Jun 12, 2015 as substantially equivalent to K123411 (Bionix Development Corp., 2013) after a 288-day review. Its family tree reaches back 2 generations to 2006.
- Decided
- Jun 12, 2015
- Review
- 288 days
- Class
- Class II
- Product code
- PDH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K053568 (2006). 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 PDH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K123411 | Little Angels Swaddling BlanketSummary page 4…ssification Name: Neonatal Phototherapy Unit Regulation Number: 880.5700 Regulatory Class: II Product Code: PDH III. PREDICATE DEVICE Little Angels Swaddling Blanket (K123411) This predicate has not been subject to a design-related recall. No reference devices were used in this submission.… | 2013 |
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 9 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All PDH devicesPDH Blanket, Neonatal Phototherapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PDH
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · PDH
Too few PDH 510(k)s in any year since 2007 to give a median.
Recalls per year · PDH
No recall names PDH since 2007.
Adverse event reports per year · PDH
No MAUDE report names PDH 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 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 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 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
To swaddle infants during neonatal phototherapy in the hospital or home setting. Single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142416 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142416: Luma Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142416
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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