510(k) · Cleared
ClearedParamax Salicylate Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Intl., Inc. · DKJ Colorimetry, Salicylate
Cleared on Apr 25, 1997 as substantially equivalent to K771805 (E.I. Dupont DE Nemours & Co., Inc., 1977) after a 151-day review. Its family tree reaches back 1 generation to 1977.
- Decided
- Apr 25, 1997
- Review
- 151 days
- Class
- Class II
- Product code
- DKJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K771805 (1977). No later device cites it as a predicate yet.
- Root · 1 generation backK771805 Aca Salicylate CalibratorE.I. Dupont DE Nemours & Co., Inc. · 1977
- This deviceK964715 Paramax Salicylate ReagentDade Intl., Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K771805 | Aca Salicylate Calibrator | E.I. Dupont DE Nemours & Co., Inc. | 1977 | — |
| 0 (this device) | K964715 | Paramax Salicylate Reagent | Dade Intl., Inc. | 1997 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DKJ? 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K771805 | Aca Salicylate CalibratorSummary page 1…Rico Building 187-67 Road 115 KM 226 Aguada, PR. 00602 The Paramax® Salicylate Reagent is substantially equivalent to its predecessor, which was cleared to market on K771805. The proposed and the predicate device are intended for use as quantitative determination of salicylate in plasma and serum. Th… | 1977 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All DKJ devicesDKJ Colorimetry, Salicylate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DKJ
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · DKJ
Too few DKJ 510(k)s in any year since 2007 to give a median.
Recalls per year · DKJ
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKJ
1in 2020
MAUDE reports naming product code DKJ, 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 | — | 1 | 1 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 1 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The proposed and the predicate device are intended for use as quantitative determination of salicylate in plasma and serum.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964715: Paramax Salicylate Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964715
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026