510(k) · Cleared
ClearedLittle Angels Swaddling Blanket
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionix Development Corp. · PDH Blanket, Neonatal Phototherapy
Cleared on Mar 7, 2013 as substantially equivalent to K053568 (Lumitex, Inc., 2006) after a 122-day review. Its family tree reaches back 1 generation to 2006. 1 later device descends from it.
- Decided
- Mar 7, 2013
- Review
- 122 days
- Class
- Class II
- Product code
- PDH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053568 (2006). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K142416Luma WrapSalter Labs · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K053568 | Bilisoft Phototherapy System | Lumitex, Inc. | 2006 | — |
| 0 (this device) | K123411 | Little Angels Swaddling Blanket | Bionix Development Corp. | 2013 | — |
| +1 | K142416 | Luma Wrap | Salter Labs | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
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 |
|---|---|---|---|
| * | K053568 | Bilisoft Phototherapy SystemSummary page 2…regulation number 880.5700, Unit, Neonatal Phototherapy, and is classified as a Class 11 device. This device has been cleared by the FDA under K053568. 5. Device Description: The Little Angels Swaddling Blanket is intended to be used as an adjunct to neonatal pho… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142416 | Luma Wrap | 2015 | 0 |
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?
How does its category compare?
All PDH devicesPDH Blanket, Neonatal Phototherapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The Little Angels Swaddling Blanket developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting.
It is intended to be used by or under the direction of a licensed physician.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K123411 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123411: Little Angels Swaddling Blanket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123411
Report an extraction error
Are you the manufacturer?
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