510(k) · Cleared
Recalled · Class II · 2019Vitros Immunodiagnostic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Clinical Diagnostics, Inc. · KHO Fluorometer, For Clinical Use
Cleared on Oct 18, 1996 after an 84-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Oct 18, 1996
- Review
- 84 days
- Class
- Class I
- Product code
- KHO
- Recalls
- 5
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK962919 Vitros Immunodiagnostic SystemJohnson & Johnson Clinical Diagnostics, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK983133 TBILAbbott Laboratories · 1998
Most influential descendants
Showing 1 of 1 · See all- K983133TBILAbbott Laboratories · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962919 | Vitros Immunodiagnostic System | Johnson & Johnson Clinical Diagnostics, Inc. | 1996 | — |
| +1 | K983133 | TBIL | Abbott Laboratories | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983133 | TBIL | 1998 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2019 | Class II | Z-1293-2019 | Software design | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems |
| Feb 20, 2019 | Class II | Z-1292-2019 | Software design | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems |
| Aug 24, 2011 | Not classified | Z-0923-2012 | Software design | Software defect; Ortho Clinical Diagnostics received complaints of observed results from diluted samples that were reported as <2.39 mIU/mL (IU/L) instead of the correct No Result, which is accompanied by an Invalid Dilution (ID) code.… |
| Aug 24, 2011 | Not classified | Z-0924-2012 | Software design | Software defect; Ortho Clinical Diagnostics received complaints of observed results from diluted samples that were reported as <2.39 mIU/mL (IU/L) instead of the correct No Result, which is accompanied by an Invalid Dilution (ID) code.… |
| Sep 29, 2005 | Not classified | Z-0137-06 | Other | When using Vitro ECi Immunodiagnostic System with Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs, results of the 1st of two required re-test replicates may be negtively biased. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K983133 (Abbott Laboratories, 1998) has gone furthest, with 0 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/K962919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962919: Vitros Immunodiagnostic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962919
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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