510(k) · Cleared
ClearedQuantex RF Plus (Latex, Buffer Standard, Control)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biokit USA, Inc. · DHR System, Test, Rheumatoid Factor
Cleared on Nov 8, 1989 after a 9-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Nov 8, 1989
- Review
- 9 days
- Class
- Class II
- Product code
- DHR
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK896271 Quantex RF Plus (Latex, Buffer Standard, Control)Biokit USA, Inc. · 1989
- Descendant · cites it directly · 1 of its ownK971777 Quantex Aso-CRP-RF ControlInstrumentation Laboratory CO · 1997
- Descendant · 2 generations on · 0 of its ownK984437 Quantex Aso-CRP-RP Control IIInstrumentation Laboratory CO · 1999
- Descendant · cites it directly · 0 of its ownK973464 Quantex RF Plus (Latex, Buffer, Standard, Control)Instrumentation Laboratory CO · 1997
Most influential descendants
Showing 3 of 3 · See all- K971777Quantex Aso-CRP-RF ControlInstrumentation Laboratory CO · 1997 · cites it directly1descendant
- K984437Quantex Aso-CRP-RP Control IIInstrumentation Laboratory CO · 1999 · 2 generations on0descendants
- K973464Quantex RF Plus (Latex, Buffer, Standard, Control)Instrumentation Laboratory CO · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K896271 | Quantex RF Plus (Latex, Buffer Standard, Control) | Biokit USA, Inc. | 1989 | — |
| +1 | K971777 | Quantex Aso-CRP-RF Control | Instrumentation Laboratory CO | 1997 | — |
| +2 | K984437 | Quantex Aso-CRP-RP Control II | Instrumentation Laboratory CO | 1999 | — |
| +1 | K973464 | Quantex RF Plus (Latex, Buffer, Standard, Control) | Instrumentation Laboratory CO | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1999 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K971777 (Instrumentation Laboratory CO, 1997) has gone furthest, with 1 descendant 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/K896271 · printed Nov 3, 2026
Cite this page
510(k) Report. “K896271: Quantex RF Plus (Latex, Buffer Standard, Control).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K896271
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026