510(k) · Cleared
ClearedMediled Phototherapy Lamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medix I.C.S.A. · LBI Unit, Neonatal Phototherapy
Cleared on Feb 27, 2009 as substantially equivalent to K022196 (Natus Medical, Inc., 2002) after a 122-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Feb 27, 2009
- Review
- 122 days
- Class
- Class II
- Product code
- LBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940996 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK940996 Olympic Bili-LiteOlympic Medical Corp. · 1994
- 1 generation backK022196 Natus Blue Light Phototherapy UnitNatus Medical, Inc. · 2002 · Recalled
- This deviceK083179 Mediled Phototherapy LampMedix I.C.S.A. · 2009
- Descendant · cites it directly · 1 of its ownK103735 Mediled MiniMedix I.C.S.A. · 2011
- Descendant · cites it directly · 0 of its ownK160745 neoBLUE compact LED Phototherapy SystemNatus Medical Incorporated · 2016
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 |
|---|---|---|---|---|---|
| −2 | K940996 | Olympic Bili-Lite | Olympic Medical Corp. | 1994 | — |
| −1 | K022196 | Natus Blue Light Phototherapy Unit | Natus Medical, Inc. | 2002 | 5 |
| 0 (this device) | K083179 | Mediled Phototherapy Lamp | Medix I.C.S.A. | 2009 | — |
| +1 | K103735 | Mediled Mini | Medix I.C.S.A. | 2011 | — |
| +1 | K160745 | neoBLUE compact LED Phototherapy System | Natus Medical Incorporated | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K022196 | Natus Blue Light Phototherapy UnitSummary page 1…e: LBI 3. Predicate Devices: The MediLED Phototherapy Lamp is substantially equivalent to the Natus Blue Light Phototherapy Unit [K022196]. 4. Intended Use Statement: INDICATIONS FOR USE: The MediLED Phototherapy Lamp is intended for th… | 2002 |
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 15 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K103735 (Medix I.C.S.A., 2011) has gone furthest, with 1 descendant 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. 2009, 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 MediLED Phototherapy Lamp is intended for the treatment for neonatal hyperbilirubinemia. The device is intended for use by healthcare professionals in a clinical setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083179 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083179: Mediled Phototherapy Lamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083179
Report an extraction error
Are you the manufacturer?
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