510(k) · Cleared
ClearedBilibee Led Phototherapy System, Model: 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Select, Inc. · LBI Unit, Neonatal Phototherapy
Cleared on Oct 30, 2007 as substantially equivalent to K022196 (Natus Medical, Inc., 2002) and 2 other predicates after a 91-day review. Its family tree reaches back 2 generations to 1988. 3 later devices descend from it.
- Decided
- Oct 30, 2007
- Review
- 91 days
- Class
- Class II
- Product code
- LBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K883779 (1988). 5 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK883779 Wallaby (TM) BlanketFiberoptic Medical Products, Inc. · 1988
- 1 generation backK991627 Wallaby 3 Phototherapy System, Model 3600Respironics, Inc. · 1999
- This deviceK072097 Bilibee Led Phototherapy System, Model: 1Medical Select, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK210289 Infant Phototherapy EquipmentBistos Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK251308 SnugLit (TM) Wearable Phototherapy System (SNGL-01-US)Thera B Medical Products · 2026
- Descendant · 2 generations on · 0 of its ownK243372 BiliWrapGerium Medical, Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883779 | Wallaby (TM) Blanket | Fiberoptic Medical Products, Inc. | 1988 | — |
| −1 | K991627 | Wallaby 3 Phototherapy System, Model 3600 | Respironics, Inc. | 1999 | — |
| 0 (this device) | K072097 | Bilibee Led Phototherapy System, Model: 1 | Medical Select, Inc. | 2007 | — |
| +1 | K210289 | Infant Phototherapy Equipment | Bistos Co., Ltd. | 2021 | — |
| +2 | K251308 | SnugLit (TM) Wearable Phototherapy System (SNGL-01-US) | Thera B Medical Products | 2026 | — |
| +2 | K243372 | BiliWrap | Gerium Medical, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K022196 | Natus Blue Light Phototherapy UnitSummary page 1…Code: LBI Predicated Devices: Natus Medical, Inc. neoBLUETM LED Phototherapy System (K022196) Respironics Wallaby®3 Phototherapy System (K991627)… | 2002 |
| * | K991627 | Wallaby 3 Phototherapy System, Model 3600Summary page 1…nc. neoBLUETM LED Phototherapy System (K022196) Respironics Wallaby®3 Phototherapy System (K991627) Medela, Inc. Bilibed® Phototherapy Unit (K984589). Reason for Submission:… | 1999 |
| * | K984589 | Phototherapy LampSummary page 1…Respironics Wallaby®3 Phototherapy System (K991627) Medela, Inc. Bilibed® Phototherapy Unit (K984589). Reason for Submission: New Device AGC-05-REG-001-MS 510(k) Submission, Medical Select BiliBee LED CONFID… | 1999 |
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 |
|---|---|---|---|
| K210289 | Infant Phototherapy Equipment | 2021 | 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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K210289 (Bistos Co., Ltd., 2021) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K022196.
How does its category compare?
All LBI devicesLBI Unit, Neonatal Phototherapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 intended use of the BiliBee LED Phototherapy System is the treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The system can be used with off-the-self AA battery pack for portability or an AC/DC regulated power supply. The BiliBee LED Phototherapy System can be used in a hospital or at home
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072097 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072097: Bilibee Led Phototherapy System, Model: 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072097
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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