510(k) · Cleared
ClearedWallaby 3 Phototherapy System, Model 3600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · LBI Unit, Neonatal Phototherapy
Cleared on May 17, 1999 as substantially equivalent to K883779 (Fiberoptic Medical Products, Inc., 1988) after a 6-day review. Its family tree reaches back 1 generation to 1988. 17 later devices descend from it.
- Decided
- May 17, 1999
- Review
- 6 days
- Class
- Class II
- Product code
- LBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K883779 (1988). 17 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK883779 Wallaby (TM) BlanketFiberoptic Medical Products, Inc. · 1988
- This deviceK991627 Wallaby 3 Phototherapy System, Model 3600Respironics, Inc. · 1999
- Descendant · cites it directly · 12 of its ownK070180 Wallaby 4Respironics Inc., Sleep & Home Respiratory Group · 2007
- Descendant · 2 generations on · 6 of its ownK072035 Resolve Uvb Phototherapy SystemAllux Medical · 2007
- Descendant · 3 generations on · 5 of its ownK170489 Skylit Phototherapy SystemSkylit Medical · 2017
- Descendant · 4 generations on · 3 of its ownK173436 Luma Light SystemLuma Therapeutics · 2018
- Descendant · cites it directly · 3 of its ownK072097 Bilibee Led Phototherapy System, Model: 1Medical Select, Inc. · 2007
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K070180Wallaby 4Respironics Inc., Sleep & Home Respiratory Group · 2007 · cites it directly12descendants
- K072035Resolve Uvb Phototherapy SystemAllux Medical · 2007 · 2 generations on6descendants
- K170489Skylit Phototherapy SystemSkylit Medical · 2017 · 3 generations on5descendants
- K173436Luma Light SystemLuma Therapeutics · 2018 · 4 generations on3descendants
- K072097Bilibee Led Phototherapy System, Model: 1Medical Select, Inc. · 2007 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883779 | Wallaby (TM) Blanket | Fiberoptic Medical Products, Inc. | 1988 | — |
| 0 (this device) | K991627 | Wallaby 3 Phototherapy System, Model 3600 | Respironics, Inc. | 1999 | — |
| +1 | K070180 | Wallaby 4 | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| +2 | K072035 | Resolve Uvb Phototherapy System | Allux Medical | 2007 | — |
| +3 | K170489 | Skylit Phototherapy System | Skylit Medical | 2017 | — |
| +4 | K173436 | Luma Light System | Luma Therapeutics | 2018 | — |
| +1 | K072097 | Bilibee Led Phototherapy System, Model: 1 | Medical Select, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K883779 | Wallaby (TM) BlanketSummary page 1…egulatory Affairs Manager Wallaby 3 Phototherapy System ™ 3600 Neonatal Phototherapy, 21 CFR 880.5700 LBI Fiberoptic Medical Products, Inc., Wallaby Il cleared under K883779 (11/14/1988) The Wallaby 3 Phototherapy System is a medical device that provides therapeutic light through a fiberoptic cable bu… | 1988 |
What descends from it? (17)
See all 172 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?
- Its one ancestor has no recall.
- Of its descendants, K070180 (Respironics Inc., Sleep & Home Respiratory Group, 2007) has gone furthest, with 12 descendants of its own.
How does its category compare?
All LBI devicesLBI Unit, Neonatal Phototherapy: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Wallaby 3 is intended to treat hyperbilirubinemia through phototherapy in a home or hospital environment.
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/K991627 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991627: Wallaby 3 Phototherapy System, Model 3600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991627
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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