510(k) · Cleared
ClearedOlympic Bili-Lite-Pad (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympic Medical Corp. · LBI Unit, Neonatal Phototherapy
Cleared on Jul 16, 1990 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jul 16, 1990
- Review
- 75 days
- Class
- Class II
- Product code
- LBI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK901987 Olympic Bili-Lite-Pad (TM)Olympic Medical Corp. · 1990
- Descendant · cites it directly · 2 of its ownK103589 Neoblue Blanket Led Phototherapy SystemNatus Medical Incorporated · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK182178 neoBLUE blanket LED Phototherapy SystemNatus Medical Incorporated · 2018
- Descendant · 2 generations on · 0 of its ownK163526 Bilicocoon™ Phototherapy SystemNeomedlight · 2017
Most influential descendants
Showing 3 of 3 · See all- K103589Neoblue Blanket Led Phototherapy SystemNatus Medical Incorporated · 2011 · cites it directly2descendants
- K182178neoBLUE blanket LED Phototherapy SystemNatus Medical Incorporated · 2018 · 2 generations on0descendants
- K163526Bilicocoon™ Phototherapy SystemNeomedlight · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K901987 | Olympic Bili-Lite-Pad (TM) | Olympic Medical Corp. | 1990 | — |
| +1 | K103589 | Neoblue Blanket Led Phototherapy System | Natus Medical Incorporated | 2011 | 3 |
| +2 | K182178 | neoBLUE blanket LED Phototherapy System | Natus Medical Incorporated | 2018 | — |
| +2 | K163526 | Bilicocoon™ Phototherapy System | Neomedlight | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103589 | Neoblue Blanket Led Phototherapy System | 2011 | 2 |
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?
- Of its descendants, K103589 (Natus Medical Incorporated, 2011) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K901987 · printed Nov 3, 2026
Cite this page
510(k) Report. “K901987: Olympic Bili-Lite-Pad (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K901987
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026