510(k) · Cleared
Recalled · 2012Skylight Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adac Laboratories · KPS System, Tomography, Computed, Emission
Cleared on Apr 5, 2000 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it. It has been recalled 13 times.
- Decided
- Apr 5, 2000
- Review
- 15 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 13
- Predicates
- 0
18 later devices descend from it, 2 citing it directly.
- This deviceK000908 Skylight Imaging SystemAdac Laboratories · 2000
- Descendant · cites it directly · 13 of its ownK020343 Surgassist System; Wireless Remote Control (Component); Wired Remote…Power Medical Interventions, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 12 of its ownK053510 IR Wireless Foot SwitchLinemaster Switch Corp. · 2006 · Recalled
- Descendant · 3 generations on · 9 of its ownK083161 Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter…Conmed Linvatec · 2009
- Descendant · 3 generations on · 8 of its ownK100638 Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless…Depuy Mitek, A Johnson & Johnson Company · 2010
- Descendant · 4 generations on · 3 of its ownK152777 Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K020343Surgassist System; Wireless Remote Control (Component); Wired Remote ControlPower Medical Interventions, Inc. · 2002 · cites it directly13descendants
- K053510IR Wireless Foot SwitchLinemaster Switch Corp. · 2006 · 2 generations on12descendants
- K083161Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100)Conmed Linvatec · 2009 · 3 generations on9descendants
- K100638Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214Depuy Mitek, A Johnson & Johnson Company · 2010 · 3 generations on8descendants
- K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000908 | Skylight Imaging System | Adac Laboratories | 2000 | — |
| +1 | K020343 | Surgassist System; Wireless Remote Control (Component); Wired Remote Control | Power Medical Interventions, Inc. | 2002 | 1 |
| +2 | K053510 | IR Wireless Foot Switch | Linemaster Switch Corp. | 2006 | 2 |
| +3 | K083161 | Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100) | Conmed Linvatec | 2009 | — |
| +3 | K100638 | Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch… | Depuy Mitek, A Johnson & Johnson Company | 2010 | — |
| +4 | K152777 | Bovie Disposable Bipolar Ablator | Bovie Medical Corporation | 2016 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 KPS? 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 KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (18)
See all 182 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 23, 2012 | Not classified | Z-1219-2012 | Software design | Incorrect Standardized Uptake Value ("SUV") values are displayed in two instances: 1. After loading PET data (with a Slope value different than 1) into the Quick Review (QR) application from a remote device; and 2. During the loading the… |
| Dec 8, 2011 | Not classified | Z-0607-2012 | Device Design | During preventative maintenance, a crack was discovered in the lower portion of the old style, non-common arm for the detector assembly, which could result in the detector dropping in an uncontrolled manner. |
| Sep 27, 2011 | Not classified | Z-0254-2012 | Device Design | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Sep 27, 2011 | Not classified | Z-0251-2012 | Device Design | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Sep 27, 2011 | Not classified | Z-0252-2012 | Device Design | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Sep 27, 2011 | Not classified | Z-0253-2012 | Device Design | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Sep 27, 2011 | Not classified | Z-0247-2012 | Device Design | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Sep 27, 2011 | Not classified | Z-0249-2012 | Device Design | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Sep 27, 2011 | Not classified | Z-0248-2012 | Device Design | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Sep 27, 2011 | Not classified | Z-0250-2012 | Device Design | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Dec 28, 2010 | Not classified | Z-1552-2011 | Other | Philips Healthcare Nuclear Medicine determined that the detector arm assembly could be compromised. |
| Dec 28, 2010 | Not classified | Z-1551-2011 | Other | Philips Healthcare Nuclear Medicine determined that the detector arm assembly could be compromised. |
| Oct 15, 2010 | Not classified | Z-0398-2011 | Component change control | Detector arm assembly may slide to hardware limit, potentially causing impact. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K020343 (Power Medical Interventions, Inc., 2002) has gone furthest, with 13 descendants of its own.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, 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 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
https://510kreport.com/device/K000908 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000908: Skylight Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000908
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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