510(k) · Cleared
ClearedSnugLit (TM) Wearable Phototherapy System (SNGL-01-US)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thera B Medical Products · LBI Unit, Neonatal Phototherapy
Cleared on Jan 15, 2026 as substantially equivalent to K210289 (Bistos Co., Ltd., 2021) after a 262-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- Jan 15, 2026
- Review
- 262 days
- Class
- Class II
- Product code
- LBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K883779 (1988). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK883779 Wallaby (TM) BlanketFiberoptic Medical Products, Inc. · 1988
- 3 generations backK991627 Wallaby 3 Phototherapy System, Model 3600Respironics, Inc. · 1999
- 2 generations backK072097 Bilibee Led Phototherapy System, Model: 1Medical Select, Inc. · 2007
- 1 generation backK210289 Infant Phototherapy EquipmentBistos Co., Ltd. · 2021
- This deviceK251308 SnugLit (TM) Wearable Phototherapy System (SNGL-01-US)Thera B Medical Products · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K883779 | Wallaby (TM) Blanket | Fiberoptic Medical Products, Inc. | 1988 | — |
| −3 | K991627 | Wallaby 3 Phototherapy System, Model 3600 | Respironics, Inc. | 1999 | — |
| −2 | K072097 | Bilibee Led Phototherapy System, Model: 1 | Medical Select, Inc. | 2007 | — |
| −1 | K210289 | Infant Phototherapy Equipment | Bistos Co., Ltd. | 2021 | — |
| 0 (this device) | K251308 | SnugLit (TM) Wearable Phototherapy System (SNGL-01-US) | Thera B Medical Products | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 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 K243372 BiliWrapscore 10.3 · 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 |
|---|---|---|---|
| * | K210289 | Infant Phototherapy EquipmentSummary page 5…880.5700 Product Code: LBI Predicate Device: 510(k) Number Device Name Manufacturer K210289 BiliTouch (Motif Phototherapy Blanket) Bistos Co., Ltd. Device Description: The SnugLit system is a… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 38 years and passes through 5 companies; a new generation was cleared every 10.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K210289.
How does its category compare?
All LBI devicesLBI Unit, Neonatal Phototherapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 SnugLit(TM) Wearable Phototherapy System is intended for use in the treatment of infant hyperbilirubinemia, commonly known as neonatal jaundice. The device can be used in a hospital or at home, by a licensed medical practitioner or by a caregiver under the supervision of a licensed medical practitioner.
The device has been designed for use with infants of weights between 1.5 – 5.5 kg (approximately 3.5 -12 lbs) and lengths between 40.5 - 57.5 cm (approximately 16 - 23 inches).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251308 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251308: SnugLit (TM) Wearable Phototherapy System (SNGL-01-US).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251308
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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