510(k) · Cleared
ClearedPhototherapy Lamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medela, Inc. · LBI Unit, Neonatal Phototherapy
Cleared on Apr 20, 1999 after a 117-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Apr 20, 1999
- Review
- 117 days
- Class
- Class II
- Product code
- LBI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK984589 Phototherapy LampMedela, Inc. · 1999
- Descendant · cites it directly · 3 of its ownK072097 Bilibee Led Phototherapy System, Model: 1Medical Select, Inc. · 2007
- Descendant · 2 generations on · 2 of its ownK210289 Infant Phototherapy EquipmentBistos Co., Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK251308 SnugLit (TM) Wearable Phototherapy System (SNGL-01-US)Thera B Medical Products · 2026
- Descendant · 3 generations on · 0 of its ownK243372 BiliWrapGerium Medical, Ltd. · 2025
Most influential descendants
Showing 4 of 4 · See all- K072097Bilibee Led Phototherapy System, Model: 1Medical Select, Inc. · 2007 · cites it directly3descendants
- K210289Infant Phototherapy EquipmentBistos Co., Ltd. · 2021 · 2 generations on2descendants
- K251308SnugLit (TM) Wearable Phototherapy System (SNGL-01-US)Thera B Medical Products · 2026 · 3 generations on0descendants
- K243372BiliWrapGerium Medical, Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984589 | Phototherapy Lamp | Medela, Inc. | 1999 | — |
| +1 | K072097 | Bilibee Led Phototherapy System, Model: 1 | Medical Select, Inc. | 2007 | — |
| +2 | K210289 | Infant Phototherapy Equipment | Bistos Co., Ltd. | 2021 | — |
| +3 | K251308 | SnugLit (TM) Wearable Phototherapy System (SNGL-01-US) | Thera B Medical Products | 2026 | — |
| +3 | K243372 | BiliWrap | Gerium Medical, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072097 | Bilibee Led Phototherapy System, Model: 1 | 2007 | 3 |
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, K072097 (Medical Select, Inc., 2007) has gone furthest, with 3 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?
Medela’s phototherapy lamp is intended for the treatment of excessive serum-bilirubin concentrations in newbotn babies.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984589 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984589: Phototherapy Lamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984589
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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