510(k) · Cleared
ClearedNanoblutm 500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical Systems, Inc. · LBI Unit, Neonatal Phototherapy
Cleared on Feb 17, 2012 as substantially equivalent to K022196 (Natus Medical, Inc., 2002) after a 108-day review. Its family tree reaches back 2 generations to 1994. 3 later devices descend from it.
- Decided
- Feb 17, 2012
- Review
- 108 days
- Class
- Class II
- Product code
- LBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940996 (1994). 3 later devices descend from it, 3 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 deviceK113206 Nanoblutm 500Draeger Medical Systems, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK172656 BiliLuxDraeger Medical Systems, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK160238 Airborne Phototherapy LightInternational Biomedical · 2016
- Descendant · cites it directly · 0 of its ownK131196 Infant Phototherapy Bilitron Sky 5006Fanem Lda · 2014
Most influential descendants
Showing 3 of 3 · 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) | K113206 | Nanoblutm 500 | Draeger Medical Systems, Inc. | 2012 | — |
| +1 | K172656 | BiliLux | Draeger Medical Systems, Inc. | 2018 | — |
| +1 | K160238 | Airborne Phototherapy Light | International Biomedical | 2016 | — |
| +1 | K131196 | Infant Phototherapy Bilitron Sky 5006 | Fanem Lda | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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 2…ght Feature NanoBlu 500 Natus® Blue Light (K022196) Intended Use For the treatment of neonatal For the treatment of neo- hyper… | 2002 |
What descends from it? (3)
3 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 18 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K172656 (Draeger Medical Systems, Inc., 2018) has gone furthest, with 0 descendants 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. 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 Dräger NanoBlu 500 LED Phototherapy Light is intended to treat neonatal hyperbilirubinemia by providing phototherapeutic light to the body of the patient. It is intended for use on the recommendation and under the supervision of healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113206: Nanoblutm 500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113206
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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