510(k) · Cleared
ClearedUvb Cabinet or Goekerman Cabinet, Model Spectra 305
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Jan 3, 1983 after a 48-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it.
- Decided
- Jan 3, 1983
- Review
- 48 days
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 2 citing it directly.
- This deviceK828654 Uvb Cabinet or Goekerman Cabinet, Model Spectra 305Daavlin Co. · 1983
- Descendant · cites it directly · 12 of its ownK050695 Flex Controlled Phototherapy EquipmentDaavlin Distributing Co. · 2005
- Descendant · cites it directly · 7 of its ownK063621 3 Series Phototherapy CabinetDaavlin Co. · 2007
- Descendant · 2 generations on · 6 of its ownK100378 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4Daavlin Distributing Co. · 2010 · Recalled
- Descendant · 2 generations on · 4 of its ownK182215 ClearLink Controlled Phototherapy EquipmentDaavlin Distributing Company · 2018 · Recalled
- Descendant · 3 generations on · 2 of its ownK210881 M Series Phototherapy EquipmentDaavlin Distributing Co. · 2021 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K050695Flex Controlled Phototherapy EquipmentDaavlin Distributing Co. · 2005 · cites it directly12descendants
- K0636213 Series Phototherapy CabinetDaavlin Co. · 2007 · cites it directly7descendants
- K1003781 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4Daavlin Distributing Co. · 2010 · 2 generations on6descendants
- K182215ClearLink Controlled Phototherapy EquipmentDaavlin Distributing Company · 2018 · 2 generations on4descendants
- K210881M Series Phototherapy EquipmentDaavlin Distributing Co. · 2021 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K828654 | Uvb Cabinet or Goekerman Cabinet, Model Spectra 305 | Daavlin Co. | 1983 | — |
| +1 | K050695 | Flex Controlled Phototherapy Equipment | Daavlin Distributing Co. | 2005 | — |
| +1 | K063621 | 3 Series Phototherapy Cabinet | Daavlin Co. | 2007 | — |
| +2 | K100378 | 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4 | Daavlin Distributing Co. | 2010 | 1 |
| +2 | K182215 | ClearLink Controlled Phototherapy Equipment | Daavlin Distributing Company | 2018 | 1 |
| +3 | K210881 | M Series Phototherapy Equipment | Daavlin Distributing Co. | 2021 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in this category? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
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?
- Of its descendants, K050695 (Daavlin Distributing Co., 2005) has gone furthest, with 12 descendants of its own.
https://510kreport.com/device/K828654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K828654: Uvb Cabinet or Goekerman Cabinet, Model Spectra 305.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K828654
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026