510(k) · Cleared
ClearedBilisoft Phototherapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumitex, Inc. · LBI Unit, Neonatal Phototherapy
Cleared on Apr 17, 2006 after a 116-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Apr 17, 2006
- Review
- 116 days
- Class
- Class II
- Product code
- LBI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK053568 Bilisoft Phototherapy SystemLumitex, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK103589 Neoblue Blanket Led Phototherapy SystemNatus Medical Incorporated · 2011 · Recalled
- Descendant · cites it directly · 1 of its ownK123411 Little Angels Swaddling BlanketBionix Development Corp. · 2013
- Descendant · 2 generations on · 0 of its ownK182178 neoBLUE blanket LED Phototherapy SystemNatus Medical Incorporated · 2018
- Descendant · 2 generations on · 0 of its ownK163526 Bilicocoon™ Phototherapy SystemNeomedlight · 2017
- Descendant · 2 generations on · 0 of its ownK142416 Luma WrapSalter Labs · 2015
Most influential descendants
Showing 5 of 5 · See all- K103589Neoblue Blanket Led Phototherapy SystemNatus Medical Incorporated · 2011 · cites it directly2descendants
- K123411Little Angels Swaddling BlanketBionix Development Corp. · 2013 · cites it directly1descendant
- K182178neoBLUE blanket LED Phototherapy SystemNatus Medical Incorporated · 2018 · 2 generations on0descendants
- K163526Bilicocoon™ Phototherapy SystemNeomedlight · 2017 · 2 generations on0descendants
- K142416Luma WrapSalter Labs · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053568 | Bilisoft Phototherapy System | Lumitex, Inc. | 2006 | — |
| +1 | K103589 | Neoblue Blanket Led Phototherapy System | Natus Medical Incorporated | 2011 | 3 |
| +1 | K123411 | Little Angels Swaddling Blanket | Bionix Development Corp. | 2013 | — |
| +2 | K182178 | neoBLUE blanket LED Phototherapy System | Natus Medical Incorporated | 2018 | — |
| +2 | K163526 | Bilicocoon™ Phototherapy System | Neomedlight | 2017 | — |
| +2 | K142416 | Luma Wrap | Salter Labs | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 LBI? 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 LBI device
- #1 K251308 SnugLit (TM) Wearable Phototherapy System…score 11.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | Ohmieda Medical, a division of Datex-Ohnieda - BiliBlanket Plus High Output Phototherapy… Named without a submission number | |
| * | — | Natus - neoBLUE LED Phototherapy Named without a submission number | |
| * | — | Medela - Bili Phototherapy Unit Named without a submission number |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K103589 (Natus Medical Incorporated, 2011) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LBI devicesLBI Unit, Neonatal Phototherapy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LBI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LBI
134in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LBI
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBI
3in 2025
MAUDE reports naming product code LBI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 91 | 0 | 1 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 2 | — | 1 | 4 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 3 | 157 | 0 | 5 |
| 2012 | 5 | 108 | 0 | 3 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 1 | — | 1 | 5 |
| 2015 | 1 | — | 1 | 6 |
| 2016 | 3 | 134 | 2 | 22 |
| 2017 | 2 | — | 0 | 577 |
| 2018 | 2 | — | 0 | 37 |
| 2019 | 1 | — | 1 | 6 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The BiliSofi Phototherapy System provides light therapy for the treatment of
hyperbilirubinemia, commonly know as neonatal jaundice, during the newborn period in
the hospital or home setting. The BiliSoft Phototherapy System emits a narrow band of
blue light considered to be the most effective in the treatment of hyperbilirubinemia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053568: Bilisoft Phototherapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053568
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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