510(k) · Cleared
ClearedBT-400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Med USA · LBI Unit, Neonatal Phototherapy
Cleared on Mar 20, 2015 as substantially equivalent to K103828 (Atom Medical Corporation, 2011) after a 212-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Mar 20, 2015
- Review
- 212 days
- Class
- Class II
- Product code
- LBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K940996 (1994). 8 ancestors in all, the oldest K883779 (1988). No later device cites it as a predicate yet.
- Root · 5 generations backK940996 Olympic Bili-LiteOlympic Medical Corp. · 1994
- 4 generations backK022196 Natus Blue Light Phototherapy UnitNatus Medical, Inc. · 2002 · Recalled
- 3 generations backK051869 Neoblue Cozy Led Phototherapy SystemNatus Medical, Inc. · 2005
- 2 generations backK070180 Wallaby 4Respironics Inc., Sleep & Home Respiratory Group · 2007
- 1 generation backK103828 Bili-Therapy Spot TypeAtom Medical Corporation · 2011
- This deviceK142332 BT-400Bio-Med USA · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K940996 | Olympic Bili-Lite | Olympic Medical Corp. | 1994 | — |
| −4 | K022196 | Natus Blue Light Phototherapy Unit | Natus Medical, Inc. | 2002 | 5 |
| −3 | K051869 | Neoblue Cozy Led Phototherapy System | Natus Medical, Inc. | 2005 | — |
| −2 | K070180 | Wallaby 4 | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| −1 | K103828 | Bili-Therapy Spot Type | Atom Medical Corporation | 2011 | — |
| 0 (this device) | K142332 | BT-400 | Bio-Med USA | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 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 |
|---|---|---|---|
| * | K103828 | Bili-Therapy Spot TypeSummary page 4…ification Panel : General Hospital. Product Code : LBI 4. Legally marketed Predicate Device K103828 Atom Medical Corp, Japan BILI-THERAPY Spot type. 5. Device Description BT-400 Neonatal… | 2011 |
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 21 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 1 other device also cites its predicate K103828.
How does its category compare?
All LBI devicesLBI Unit, Neonatal Phototherapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
BT-400 is the Phototherapy unit intended for the treatment of Neonatal
Hyperbilirubinemia caused by Indirect Hyperbilirubinemia.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142332: BT-400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142332
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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