510(k) · Cleared
ClearedInfant Phototherapy Equipment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bistos Co., Ltd. · LBI Unit, Neonatal Phototherapy
Cleared on May 28, 2021 as substantially equivalent to K072097 (Medical Select, Inc., 2007) after a 115-day review. Its family tree reaches back 3 generations to 1988. 2 later devices descend from it.
- Decided
- May 28, 2021
- Review
- 115 days
- Class
- Class II
- Product code
- LBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K883779 (1988). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK883779 Wallaby (TM) BlanketFiberoptic Medical Products, Inc. · 1988
- 2 generations backK991627 Wallaby 3 Phototherapy System, Model 3600Respironics, Inc. · 1999
- 1 generation backK072097 Bilibee Led Phototherapy System, Model: 1Medical Select, Inc. · 2007
- This deviceK210289 Infant Phototherapy EquipmentBistos Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK251308 SnugLit (TM) Wearable Phototherapy System (SNGL-01-US)Thera B Medical Products · 2026
- Descendant · cites it directly · 0 of its ownK243372 BiliWrapGerium Medical, Ltd. · 2025
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 |
|---|---|---|---|---|---|
| −3 | K883779 | Wallaby (TM) Blanket | Fiberoptic Medical Products, Inc. | 1988 | — |
| −2 | K991627 | Wallaby 3 Phototherapy System, Model 3600 | Respironics, Inc. | 1999 | — |
| −1 | K072097 | Bilibee Led Phototherapy System, Model: 1 | Medical Select, Inc. | 2007 | — |
| 0 (this device) | K210289 | Infant Phototherapy Equipment | Bistos Co., Ltd. | 2021 | — |
| +1 | K251308 | SnugLit (TM) Wearable Phototherapy System (SNGL-01-US) | Thera B Medical Products | 2026 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K072097 | Bilibee Led Phototherapy System, Model: 1Summary page 4…Specialty/510(k) review General Hospital Panel III. PREDICATE DEVICE Primary Predicate device BiliBee K072097 Illumination Technologies, LLC Page 1 / 7 === P… | 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 33 years and passes through 4 companies; a new generation was cleared every 10.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K251308 (Thera B Medical Products, 2026) has gone furthest, with 0 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. 2021, 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 BiliTouchTM, model Motif Phototherapy Blanket and Infant Phototherapy Equipment, model BT-450 are indicated for use
to 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 devices can be used in a hospital or at home.
The device is designed to use for patient population described in the infant, who is age up to 3 months and weight less than 10
kg.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210289: Infant Phototherapy Equipment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210289
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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