510(k) · Cleared
Recalled · Class II · 2013Bright Embrace Model SBL60
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Physician Engineered Products, Inc. · LBI Unit, Neonatal Phototherapy
Cleared on Feb 3, 2012 as substantially equivalent to K974830 (Physician Engineered Products, Inc., 1998) after a 343-day review. Its family tree reaches back 1 generation to 1998. It has been recalled once.
- Decided
- Feb 3, 2012
- Review
- 343 days
- Class
- Class II
- Product code
- LBI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974830 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK974830 Ultra Bili LightPhysician Engineered Products, Inc. · 1998
- This deviceK110550 Bright Embrace Model SBL60Physician Engineered Products, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974830 | Ultra Bili Light | Physician Engineered Products, Inc. | 1998 | — |
| 0 (this device) | K110550 | Bright Embrace Model SBL60 | Physician Engineered Products, Inc. | 2012 | — |
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 |
|---|---|---|---|
| * | K974830 | Ultra Bili LightSummary page 1…ulation number: 21 CFR 880.5700 Classification: Class 11 Product Code: LBI Predicate Device: Physician Engineered Products, inc. - Ultra Bili Light (K974830) Device Description: The Bright Embrace Model SBL60 is a single-patient, portable phototherapy light that was specifically design… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2013 | Class II | Z-2486-2015 | Device Design | Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K974830.
How does its category compare?
All LBI devicesLBI Unit, Neonatal Phototherapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Bright Embrace Model SBL6O phototherapy light is intended for the treatment of neonatal hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath and around the neonate. The Bright Embrace can be used in a clinical setting or in the home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110550 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110550: Bright Embrace Model SBL60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110550
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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