510(k) · Cleared
ClearedAirborne Phototherapy Light
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Biomedical · LBI Unit, Neonatal Phototherapy
Cleared on Jun 14, 2016 as substantially equivalent to K103828 (Atom Medical Corporation, 2011) and 1 other predicate after a 134-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Jun 14, 2016
- Review
- 134 days
- Class
- Class II
- Product code
- LBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K940996 (1994). 9 ancestors in all, the oldest K883779 (1988). No later device cites it as a predicate yet.
- Root · 5 generations backK940996 Olympic Bili-LiteOlympic Medical Corp. · 1994
- 4 generations backK022196 Natus Blue Light Phototherapy UnitNatus Medical, Inc. · 2002 · Recalled
- 3 generations backK051869 Neoblue Cozy Led Phototherapy SystemNatus Medical, Inc. · 2005
- 2 generations backK070180 Wallaby 4Respironics Inc., Sleep & Home Respiratory Group · 2007
- 1 generation backK103828 Bili-Therapy Spot TypeAtom Medical Corporation · 2011
- This deviceK160238 Airborne Phototherapy LightInternational Biomedical · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K940996 | Olympic Bili-Lite | Olympic Medical Corp. | 1994 | — |
| −4 | K022196 | Natus Blue Light Phototherapy Unit | Natus Medical, Inc. | 2002 | 5 |
| −3 | K051869 | Neoblue Cozy Led Phototherapy System | Natus Medical, Inc. | 2005 | — |
| −2 | K070180 | Wallaby 4 | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| −1 | K103828 | Bili-Therapy Spot Type | Atom Medical Corporation | 2011 | — |
| 0 (this device) | K160238 | Airborne Phototherapy Light | International Biomedical | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K103828 | Bili-Therapy Spot TypeSummary page 4…Number: 21 CFR 880.5700 Product Code: LBI Predicate Device: Atom Medical – Bili-Therapy Spot Type – k103828 Draeger Medical Systems – NanoBlu 500 – k113206 Device Description The Airborne Observation and… | 2011 |
| * | K113206 | Nanoblutm 500Summary page 4…roduct Code: LBI Predicate Device: Atom Medical – Bili-Therapy Spot Type – k103828 Draeger Medical Systems – NanoBlu 500 – k113206 Device Description The Airborne Observation and Phototherapy Light is an LED phototherapy (and observation) light. The LED light… | 2012 |
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 22 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 1 other device also cites its predicate K103828.
How does its category compare?
All LBI devicesLBI Unit, Neonatal Phototherapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Airborne Phototherapy Light System is intended to be used in one of two modes: observation light mode or phototherapy light mode. The observation light mode utilizes white light and is intended to be used as auxiliary lighting that supplements the ambient lighting. The phototherapy light mode utilizes blue light and is intended to be used in the treatment of neonatal hyperbilirubinemia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160238 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160238: Airborne Phototherapy Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160238
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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