510(k) · Cleared
ClearedWallaby 4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics Inc., Sleep & Home Respiratory Group · LBI Unit, Neonatal Phototherapy
Cleared on May 18, 2007 as substantially equivalent to K991627 (Respironics, Inc., 1999) and 2 other predicates after a 119-day review. Its family tree reaches back 3 generations to 1994. 12 later devices descend from it.
- Decided
- May 18, 2007
- Review
- 119 days
- Class
- Class II
- Product code
- LBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K940996 (1994). 6 ancestors in all, the oldest K883779 (1988). 12 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK940996 Olympic Bili-LiteOlympic Medical Corp. · 1994
- 2 generations backK022196 Natus Blue Light Phototherapy UnitNatus Medical, Inc. · 2002 · Recalled
- 1 generation backK051869 Neoblue Cozy Led Phototherapy SystemNatus Medical, Inc. · 2005
- This deviceK070180 Wallaby 4Respironics Inc., Sleep & Home Respiratory Group · 2007
- Descendant · cites it directly · 6 of its ownK072035 Resolve Uvb Phototherapy SystemAllux Medical · 2007
- Descendant · 2 generations on · 5 of its ownK170489 Skylit Phototherapy SystemSkylit Medical · 2017
- Descendant · 3 generations on · 3 of its ownK173436 Luma Light SystemLuma Therapeutics · 2018
- Descendant · 4 generations on · 2 of its ownK192642 308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd. · 2020
- Descendant · cites it directly · 2 of its ownK103828 Bili-Therapy Spot TypeAtom Medical Corporation · 2011
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K072035Resolve Uvb Phototherapy SystemAllux Medical · 2007 · cites it directly6descendants
- K170489Skylit Phototherapy SystemSkylit Medical · 2017 · 2 generations on5descendants
- K173436Luma Light SystemLuma Therapeutics · 2018 · 3 generations on3descendants
- K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd. · 2020 · 4 generations on2descendants
- K103828Bili-Therapy Spot TypeAtom Medical Corporation · 2011 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940996 | Olympic Bili-Lite | Olympic Medical Corp. | 1994 | — |
| −2 | K022196 | Natus Blue Light Phototherapy Unit | Natus Medical, Inc. | 2002 | 5 |
| −1 | K051869 | Neoblue Cozy Led Phototherapy System | Natus Medical, Inc. | 2005 | — |
| 0 (this device) | K070180 | Wallaby 4 | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| +1 | K072035 | Resolve Uvb Phototherapy System | Allux Medical | 2007 | — |
| +2 | K170489 | Skylit Phototherapy System | Skylit Medical | 2017 | — |
| +3 | K173436 | Luma Light System | Luma Therapeutics | 2018 | — |
| +4 | K192642 | 308nm Excimer System | Chongqing Peninsula Medical Technology Co., Ltd. | 2020 | — |
| +1 | K103828 | Bili-Therapy Spot Type | Atom Medical Corporation | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K991627 | Wallaby 3 Phototherapy System, Model 3600Summary page 1…Class II Appropriate Classification Panel General Hospital Product Code LBI Predicate Devices Respironics, Inc. Wallaby 3 (K991627) Natus Medical, Inc. neoBLUE cozy LED Phototherapy System (… | 1999 |
| * | K051869 | Neoblue Cozy Led Phototherapy SystemSummary page 1…Respironics, Inc. Wallaby 3 (K991627) Natus Medical, Inc. neoBLUE cozy LED Phototherapy System (K051869) Natus Medical, Inc. Blue Light Phototherapy Unit (K022196) Reason for submission… | 2005 |
| * | K022196 | Natus Blue Light Phototherapy UnitSummary page 1…c. neoBLUE cozy LED Phototherapy System (K051869) Natus Medical, Inc. Blue Light Phototherapy Unit (K022196) Reason for submission Modified design ©2007 Respironics Inc. 04/25107… | 2002 |
What descends from it? (12)
See all 124 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 13 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K072035 (Allux Medical, 2007) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K991627.
How does its category compare?
All LBI devicesLBI Unit, Neonatal Phototherapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Bili-Tx is intended to treat hyperbilirubinemia through phototherapy in a home or hospital/institutional environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070180 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070180: Wallaby 4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070180
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