510(k) · Cleared
ClearedNeoblue Cozy Led Phototherapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Medical, Inc. · LBI Unit, Neonatal Phototherapy
Cleared on Oct 7, 2005 as substantially equivalent to K962612 (Medela, Inc., 1996) and 1 other predicate after an 88-day review. Its family tree reaches back 2 generations to 1994. 17 later devices descend from it.
- Decided
- Oct 7, 2005
- Review
- 88 days
- Class
- Class II
- Product code
- LBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K940996 (1994). 3 ancestors in all. 17 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK940996 Olympic Bili-LiteOlympic Medical Corp. · 1994
- 1 generation backK022196 Natus Blue Light Phototherapy UnitNatus Medical, Inc. · 2002 · Recalled
- This deviceK051869 Neoblue Cozy Led Phototherapy SystemNatus Medical, Inc. · 2005
- Descendant · cites it directly · 12 of its ownK070180 Wallaby 4Respironics Inc., Sleep & Home Respiratory Group · 2007
- Descendant · 2 generations on · 6 of its ownK072035 Resolve Uvb Phototherapy SystemAllux Medical · 2007
- Descendant · 3 generations on · 5 of its ownK170489 Skylit Phototherapy SystemSkylit Medical · 2017
- Descendant · 4 generations on · 3 of its ownK173436 Luma Light SystemLuma Therapeutics · 2018
- Descendant · 5 generations on · 2 of its ownK192642 308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd. · 2020
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K070180Wallaby 4Respironics Inc., Sleep & Home Respiratory Group · 2007 · cites it directly12descendants
- K072035Resolve Uvb Phototherapy SystemAllux Medical · 2007 · 2 generations on6descendants
- K170489Skylit Phototherapy SystemSkylit Medical · 2017 · 3 generations on5descendants
- K173436Luma Light SystemLuma Therapeutics · 2018 · 4 generations on3descendants
- K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd. · 2020 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940996 | Olympic Bili-Lite | Olympic Medical Corp. | 1994 | — |
| −1 | K022196 | Natus Blue Light Phototherapy Unit | Natus Medical, Inc. | 2002 | 5 |
| 0 (this device) | K051869 | Neoblue Cozy Led Phototherapy System | Natus Medical, Inc. | 2005 | — |
| +1 | K070180 | Wallaby 4 | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| +2 | K072035 | Resolve Uvb Phototherapy System | Allux Medical | 2007 | — |
| +3 | K170489 | Skylit Phototherapy System | Skylit Medical | 2017 | — |
| +4 | K173436 | Luma Light System | Luma Therapeutics | 2018 | — |
| +5 | K192642 | 308nm Excimer System | Chongqing Peninsula Medical Technology Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K962612 | Bilibed Phototherapy LampSummary page 4…py Light Trade Name Natusc) neoBLUE cozy systemPhototherapy Unit Predicate Devices Medela Bilibed, K962612 Natus Blue Light Phototherapy Unit, K022 196 Device Description The neol3… | 1996 |
| * | K022196 | Natus Blue Light Phototherapy UnitSummary page 4…eoBLUE cozy systemPhototherapy Unit Predicate Devices Medela Bilibed, K962612 Natus Blue Light Phototherapy Unit, K022 196 Device Description The neol3LUE cozy system is a portable phototherapy light that delivers… | 2002 |
What descends from it? (17)
See all 173 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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 8.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K070180 (Respironics Inc., Sleep & Home Respiratory Group, 2007) has gone furthest, with 12 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 neoBLUE cozy phototherapy light is intended for the treatment for neonatal hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath the baby. The neoBLUE cozy system must be used within a patient enclosure, such as a bassinet, an open crib, a warming table or an incubator. The neoBLUE cozy system can be used in a clinical setting or in the home.
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/K051869 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051869: Neoblue Cozy Led Phototherapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051869
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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