510(k) · Cleared
ClearedNeonatal Phototherapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avalon Biomedical (Shenzhen) Limited · LBI Unit, Neonatal Phototherapy
Cleared on Oct 5, 2020 as substantially equivalent to K070180 (Respironics Inc., Sleep & Home Respiratory Group, 2007) after a 272-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Oct 5, 2020
- Review
- 272 days
- Class
- Class II
- Product code
- LBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K940996 (1994). 7 ancestors in all, the oldest K883779 (1988). No later device cites it as a predicate yet.
- Root · 4 generations backK940996 Olympic Bili-LiteOlympic Medical Corp. · 1994
- 3 generations backK022196 Natus Blue Light Phototherapy UnitNatus Medical, Inc. · 2002 · Recalled
- 2 generations backK051869 Neoblue Cozy Led Phototherapy SystemNatus Medical, Inc. · 2005
- 1 generation backK070180 Wallaby 4Respironics Inc., Sleep & Home Respiratory Group · 2007
- This deviceK200031 Neonatal Phototherapy SystemAvalon Biomedical (Shenzhen) Limited · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K940996 | Olympic Bili-Lite | Olympic Medical Corp. | 1994 | — |
| −3 | K022196 | Natus Blue Light Phototherapy Unit | Natus Medical, Inc. | 2002 | 5 |
| −2 | K051869 | Neoblue Cozy Led Phototherapy System | Natus Medical, Inc. | 2005 | — |
| −1 | K070180 | Wallaby 4 | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| 0 (this device) | K200031 | Neonatal Phototherapy System | Avalon Biomedical (Shenzhen) Limited | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 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? (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 |
|---|---|---|---|
| * | K070180 | Wallaby 4Summary page 4…ame: Neonatal phototherapy unit Device Class: Ⅱ Product Code: LBI Panel: General Hospital Regulation Number: 21 CFR 880.5700 3. Predicate Device: 510(k) Number: K070180 Device Name and Model: Bili-Tx Manufacturer Name: Respironics Inc. 5-1 === P… | 2007 |
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 26 years and passes through 4 companies; a new generation was cleared every 8.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 3 other devices also cite its predicate K070180.
How does its category compare?
All LBI devicesLBI Unit, Neonatal Phototherapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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 Neonatal Phototherapy System, Model: KANGALITE is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates: gestational age >38 weeks and weight within 2500-4500 grams. It can be used in the clinical setting or in the home environment. It should be used for neonates whom phototherapy has been prescribed. Contraindication The Neonatal Phototherapy System, Model: KANGALITE should NOT be used in cases of: (a)…
Read the full statement (109 words)
The Neonatal Phototherapy System, Model: KANGALITE is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates: gestational age >38 weeks and weight within 2500-4500 grams. It can be used in the clinical setting or in the home environment. It should be used for neonates whom phototherapy has been prescribed.
Contraindication
The Neonatal Phototherapy System, Model: KANGALITE should NOT be used in cases of:
(a) Congenital porphyria or a family history of porphyria
(b) Concomitant use of drugs or agents that are photosensitizers
A use that does not take into account these contraindications may lead to an ineffective treatment or to potential risks to the patient’s health.
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/K200031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200031: Neonatal 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/K200031
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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