510(k) · Cleared
ClearedN Latex RF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Behring Diagnostics, Inc. · DHR System, Test, Rheumatoid Factor
Cleared on Oct 20, 1994 after a 168-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Oct 20, 1994
- Review
- 168 days
- Class
- Class II
- Product code
- DHR
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK942328 N Latex RFBehring Diagnostics, Inc. · 1994
- Descendant · cites it directly · 2 of its ownK963048 Immage System Rheumatoid Factor (RF) ReagentBeckman Instruments, Inc. · 1996 · Recalled
- Descendant · cites it directly · 1 of its ownK963292 Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1996 · Recalled
- Descendant · cites it directly · 0 of its ownK071247 N Latex RF KitDade Behring, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK031650 Ferritin Generation 2Roche Diagnostics Corp. · 2003
- Descendant · 2 generations on · 0 of its ownK971602 Array Systems Rheumatoid Factor (Rfmpe) ReagentBeckman Instruments, Inc. · 1997
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K963048Immage System Rheumatoid Factor (RF) ReagentBeckman Instruments, Inc. · 1996 · cites it directly2descendants
- K963292Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1996 · cites it directly1descendant
- K071247N Latex RF KitDade Behring, Inc. · 2007 · cites it directly0descendants
- K031650Ferritin Generation 2Roche Diagnostics Corp. · 2003 · 2 generations on0descendants
- K971602Array Systems Rheumatoid Factor (Rfmpe) ReagentBeckman Instruments, Inc. · 1997 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942328 | N Latex RF | Behring Diagnostics, Inc. | 1994 | — |
| +1 | K963048 | Immage System Rheumatoid Factor (RF) Reagent | Beckman Instruments, Inc. | 1996 | 2 |
| +1 | K963292 | Cobas Integra Reagent Cassettes & Ancillary Reagents | Roche Diagnostic Systems, Inc. | 1996 | 2 |
| +1 | K071247 | N Latex RF Kit | Dade Behring, Inc. | 2007 | — |
| +2 | K031650 | Ferritin Generation 2 | Roche Diagnostics Corp. | 2003 | — |
| +2 | K971602 | Array Systems Rheumatoid Factor (Rfmpe) Reagent | Beckman Instruments, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 2003 | 1 | 0 |
| 2007 | 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 DHR? 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? (7)
4 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, K963048 (Beckman Instruments, Inc., 1996) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DHR devicesDHR System, Test, Rheumatoid Factor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DHR
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · DHR
Too few DHR 510(k)s in any year since 2007 to give a median.
Recalls per year · DHR
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHR
2in 2025
MAUDE reports naming product code DHR, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 19 |
| 2011 | 1 | — | 3 | 400 |
| 2012 | 0 | — | 2 | 91 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 2 | 1 |
| 2019 | 1 | — | 1 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K942328 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942328: N Latex RF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942328
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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