510(k) · Cleared
Recalled · Class III · 2016Auto Delfia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wallac OY · KHO Fluorometer, For Clinical Use
Cleared on May 23, 1994 after a 214-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled 3 times.
- Decided
- May 23, 1994
- Review
- 214 days
- Class
- Class I
- Product code
- KHO
- Recalls
- 3
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK935047 Auto DelfiaWallac OY · 1994
- Descendant · cites it directly · 4 of its ownK042425 Autodelfia Neonatal 17A-OH-Progesterone KitWallac OY · 2004
- Descendant · 2 generations on · 1 of its ownK081922 Autodelfia Neonatal 17A-OH-Progesterone KitWallac OY · 2009
- Descendant · 3 generations on · 0 of its ownK100682 GSP Neonatal 17A-OH-Progesterone Kit Model: 3305-001UWallac OY · 2010
- Descendant · cites it directly · 0 of its ownK090846 GSP Instrument and GSP Neonatal HTSH KitPerkinelmer, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 0 of its ownK060452 Accuwell 17-Alpha-Hydroxyproesterone Enzyme Immunoassay with Models…Neo-Genesis · 2007
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K042425Autodelfia Neonatal 17A-OH-Progesterone KitWallac OY · 2004 · cites it directly4descendants
- K081922Autodelfia Neonatal 17A-OH-Progesterone KitWallac OY · 2009 · 2 generations on1descendant
- K100682GSP Neonatal 17A-OH-Progesterone Kit Model: 3305-001UWallac OY · 2010 · 3 generations on0descendants
- K090846GSP Instrument and GSP Neonatal HTSH KitPerkinelmer, Inc. · 2009 · cites it directly0descendants
- K060452Accuwell 17-Alpha-Hydroxyproesterone Enzyme Immunoassay with Models 6015XX-EcahNeo-Genesis · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935047 | Auto Delfia | Wallac OY | 1994 | — |
| +1 | K042425 | Autodelfia Neonatal 17A-OH-Progesterone Kit | Wallac OY | 2004 | — |
| +2 | K081922 | Autodelfia Neonatal 17A-OH-Progesterone Kit | Wallac OY | 2009 | — |
| +3 | K100682 | GSP Neonatal 17A-OH-Progesterone Kit Model: 3305-001U | Wallac OY | 2010 | — |
| +1 | K090846 | GSP Instrument and GSP Neonatal HTSH Kit | Perkinelmer, Inc. | 2009 | 4 |
| +2 | K060452 | Accuwell 17-Alpha-Hydroxyproesterone Enzyme Immunoassay with Models 6015XX-Ecah | Neo-Genesis | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 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 KHO? 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? (6)
2 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 |
|---|---|---|---|---|
| Dec 21, 2016 | Class III | Z-1102-2017 | Software design | AutoDELFIA System with Version 3.0 Software: Potential plate loading failures |
| Dec 21, 2016 | Class III | Z-1101-2017 | Software design | AutoDELFIA System with Version 3.0 Software: Potential plate loading failures |
| Dec 21, 2016 | Class III | Z-1100-2017 | Software design | AutoDELFIA System with Version 3.0 Software: Potential plate loading failures |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042425 (Wallac OY, 2004) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KHO devicesKHO Fluorometer, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KHO
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · KHO
Too few KHO 510(k)s in any year since 2007 to give a median.
Recalls per year · KHO
7in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHO
178in 2025
MAUDE reports naming product code KHO, 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 | 0 | — | 0 | 5 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 24 |
| 2010 | 0 | — | 0 | 49 |
| 2011 | 0 | — | 2 | 29 |
| 2012 | 1 | — | 1 | 68 |
| 2013 | 0 | — | 0 | 53 |
| 2014 | 0 | — | 2 | 65 |
| 2015 | 0 | — | 0 | 30 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 0 | — | 4 | 152 |
| 2018 | 0 | — | 7 | 2,123 |
| 2019 | 0 | — | 0 | 440 |
| 2020 | 0 | — | 0 | 257 |
| 2021 | 0 | — | 0 | 213 |
| 2022 | 0 | — | 0 | 224 |
| 2023 | 0 | — | 0 | 260 |
| 2024 | 0 | — | 0 | 168 |
| 2025 | 0 | — | 0 | 178 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K935047 · printed Nov 5, 2026
Cite this page
510(k) Report. “K935047: Auto Delfia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K935047
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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