510(k) · Cleared
ClearedBili-Therapy Spot Type
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atom Medical Corporation · LBI Unit, Neonatal Phototherapy
Cleared on Mar 29, 2011 as substantially equivalent to K070180 (Respironics Inc., Sleep & Home Respiratory Group, 2007) after a 91-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it.
- Decided
- Mar 29, 2011
- Review
- 91 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). 2 later devices descend from it, 2 citing it directly.
- 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 deviceK103828 Bili-Therapy Spot TypeAtom Medical Corporation · 2011
- Descendant · cites it directly · 0 of its ownK160238 Airborne Phototherapy LightInternational Biomedical · 2016
- Descendant · cites it directly · 0 of its ownK142332 BT-400Bio-Med USA · 2015
Most influential descendants
Showing 2 of 2 · See allView 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) | K103828 | Bili-Therapy Spot Type | Atom Medical Corporation | 2011 | — |
| +1 | K160238 | Airborne Phototherapy Light | International Biomedical | 2016 | — |
| +1 | K142332 | BT-400 | Bio-Med USA | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 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 1…al phototherapy unit. CFR 880.5700 Device: BILl-THERAPY Spot Predicate Device: Respironics - Bili-Tx K070180 Device Description: The Bil-THERAPY Spot Type is an overhead unit available in two versions: " Arm * Stand The BILI-TI-E… | 2007 |
What descends from it? (2)
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?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K160238 (International Biomedical, 2016) has gone furthest, with 0 descendants of its own.
- 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. 2011, 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 BILI-THERAPY Spot Type is a phototherapy unit intended for the treatment of neonatal hyperbilirubinemia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103828 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103828: Bili-Therapy Spot Type.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103828
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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