510(k) · Cleared
ClearedAca Ammonia Analytical Test Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E.I. Dupont DE Nemours & Co., Inc. · JIF Enzymatic Method, Ammonia
Cleared on Apr 8, 1977 after a 44-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Apr 8, 1977
- Review
- 44 days
- Class
- Class I
- Product code
- JIF
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK770363 Aca Ammonia Analytical Test PackE.I. Dupont DE Nemours & Co., Inc. · 1977
- Descendant · cites it directly · 0 of its ownK984402 Synchron Systems Ammonia (Amm) ReagentBeckman Coulter, Inc. · 1999 · Recalled
- Descendant · cites it directly · 0 of its ownK964565 Paramax Ammonia and Ammonia Blank ReagentDade Intl., Inc. · 1996
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K770363 | Aca Ammonia Analytical Test Pack | E.I. Dupont DE Nemours & Co., Inc. | 1977 | — |
| +1 | K984402 | Synchron Systems Ammonia (Amm) Reagent | Beckman Coulter, Inc. | 1999 | 1 |
| +1 | K964565 | Paramax Ammonia and Ammonia Blank Reagent | Dade Intl., Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 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 JIF? 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? (2)
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, K984402 (Beckman Coulter, Inc., 1999) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JIF devicesJIF Enzymatic Method, Ammonia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIF
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JIF
Too few JIF 510(k)s in any year since 2007 to give a median.
Recalls per year · JIF
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIF
5in 2025
MAUDE reports naming product code JIF, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 1 | 3 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K770363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K770363: Aca Ammonia Analytical Test Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K770363
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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