510(k) · Cleared
Recalled · Class II · 2017Natus Blue Light Phototherapy Unit
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 Sep 19, 2002 as substantially equivalent to K940996 (Olympic Medical Corp., 1994) after a 76-day review. Its family tree reaches back 1 generation to 1994. 29 later devices descend from it. It has been recalled 5 times.
- Decided
- Sep 19, 2002
- Review
- 76 days
- Class
- Class II
- Product code
- LBI
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940996 (1994). 29 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK940996 Olympic Bili-LiteOlympic Medical Corp. · 1994
- This deviceK022196 Natus Blue Light Phototherapy UnitNatus Medical, Inc. · 2002
- Descendant · cites it directly · 17 of its ownK051869 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 · cites it directly · 6 of its ownK072035 Resolve Uvb Phototherapy SystemAllux Medical · 2007
- Descendant · 2 generations on · 5 of its ownK170489 Skylit Phototherapy SystemSkylit Medical · 2017
- Descendant · 3 generations on · 3 of its ownK173436 Luma Light SystemLuma Therapeutics · 2018
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K051869Neoblue Cozy Led Phototherapy SystemNatus Medical, Inc. · 2005 · cites it directly17descendants
- K070180Wallaby 4Respironics Inc., Sleep & Home Respiratory Group · 2007 · cites it directly12descendants
- K072035Resolve Uvb Phototherapy SystemAllux Medical · 2007 · cites it directly6descendants
- K170489Skylit Phototherapy SystemSkylit Medical · 2017 · 2 generations on5descendants
- K173436Luma Light SystemLuma Therapeutics · 2018 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940996 | Olympic Bili-Lite | Olympic Medical Corp. | 1994 | — |
| 0 (this device) | K022196 | Natus Blue Light Phototherapy Unit | Natus Medical, Inc. | 2002 | — |
| +1 | K051869 | Neoblue Cozy Led Phototherapy System | Natus Medical, Inc. | 2005 | — |
| +1 | K070180 | Wallaby 4 | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| +1 | K072035 | Resolve Uvb Phototherapy System | Allux Medical | 2007 | — |
| +2 | K170489 | Skylit Phototherapy System | Skylit Medical | 2017 | — |
| +3 | K173436 | Luma Light System | Luma Therapeutics | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K940996 | Olympic Bili-LiteSummary page 1…Trade name Natus@ Blue Light Phototherapy Unit 3. Predicate Device Olympic Bili-Light, Model 33, K940996 4. Device Description The Natus Blue Light Phototherapy Unit is a floor-standing, mobile photother… | 1994 |
What descends from it? (29)
See all 298 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051869 | Neoblue Cozy Led Phototherapy System | 2005 | 17 |
| K070180 | Wallaby 4 | 2007 | 12 |
| K072035 | Resolve Uvb Phototherapy System | 2007 | 6 |
| K113206 | Nanoblutm 500 | 2012 | 3 |
| K072097 | Bilibee Led Phototherapy System, Model: 1 | 2007 | 3 |
| K083179 | Mediled Phototherapy Lamp | 2009 | 2 |
| K103735 | Mediled Mini | 2011 | 1 |
| K160305 | neoBLUE® LED Phototherapy System | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 3, 2017 | Class II | Z-1924-2017 | Component change control | The second generation neoBLUE 2 lights with a black band, sold from 2003 to 2008, are recalled so it will eliminate the possibility that a neoBLUE system may have a replacement board installed which allows it to be used at a higher… |
| Apr 11, 2016 | Class II | Z-2001-2016 | Labeling False and Misleading | The firm is adding the warning statement to the Instruction for Use for the neoBLUE LED Phototherapy System and provide a laminated Quick Guide to affix to each device. |
| Aug 5, 2015 | Class II | Z-0149-2016 | No Marketing Application | The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared intensity statement settings so the output intensity aligns precisely with the information listed in the cleared 510(k) submission. |
| Nov 19, 2014 | Class II | Z-0847-2015 | Other | Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the system will exhibit a higher light intensity output than the original device. While… |
| Oct 1, 2009 | Not classified | Z-0420-2010 | Device Design | The clamp connecting the neoBLUE mini phototherapy light to the accessory pole stand can sustain stress fractures or break when excessive force is used when tightening the clamp. No injuries have been reported. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K051869 (Natus Medical, Inc., 2005) has gone furthest, with 17 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 NatusO Blue Light Phototherapy Unit is a floor-stand, mobile, phototherapy light intended for the treatment of neonatal hyperbilirubinemia. The device can be used for infants in a bassinet, incubator, open bed, or radiant warmer.
It emits a narrow band of blue light considered to be the most effective in the degradation of bilirubin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022196: Natus Blue Light Phototherapy Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022196
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