510(k) · Decided
Recalled · Class I · 2026Enteron Abdominal Paracentesis Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endovations · KDD Kit, Surgical Instrument, Disposable
Cleared on Dec 4, 1987 after a 60-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 2 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 3 times, including a Class I recall.
- Decided
- Dec 4, 1987
- Review
- 60 days
- Class
- Class I
- Product code
- KDD
- Recalls
- 3 (1 Class I)
- Predicates
- 0
1 later device descends from it, 1 citing it directly. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- This deviceK874063 Enteron Abdominal Paracentesis TrayEndovations · 1987
- Descendant · cites it directly · 0 of its ownK960456 Denver Paracentesis Needle (60-1200) Denver Paracentesis Needle with…Denver Biomaterials, Inc. · 1996
Most influential descendants
Showing 1 of 1 · See all- K960456Denver Paracentesis Needle (60-1200) Denver Paracentesis Needle with Drainage Line…Denver Biomaterials, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K874063 | Enteron Abdominal Paracentesis Tray | Endovations | 1987 | — |
| +1 | K960456 | Denver Paracentesis Needle (60-1200) Denver Paracentesis Needle with Drainage… | Denver Biomaterials, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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.
1 device in this family has a Class I recall. 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K960456 | Denver Paracentesis Needle (60-1200) Denver Paracentesis Needle with Drainage Line… | 1996 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2026 | Class I | Z-2386-2026 | Nonconforming Material/Component | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a… |
| Apr 11, 2018 | Class II | Z-1965-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Oct 24, 2017 | Class II | Z-1297-2018 | Component design/selection | Product packaging may not be completely sealed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K960456 (Denver Biomaterials, Inc., 1996) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KDD devicesKDD Kit, Surgical Instrument, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KDD
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · KDD
Too few KDD 510(k)s in any year since 2007 to give a median.
Recalls per year · KDD
12so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KDD
33in 2025
MAUDE reports naming product code KDD, 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 | — | 2 | 0 |
| 2008 | 1 | — | 5 | 0 |
| 2009 | 0 | — | 7 | 0 |
| 2010 | 0 | — | 4 | 3 |
| 2011 | 0 | — | 0 | 8 |
| 2012 | 0 | — | 1 | 5 |
| 2013 | 0 | — | 0 | 44 |
| 2014 | 0 | — | 0 | 25 |
| 2015 | 0 | — | 3 | 54 |
| 2016 | 0 | — | 0 | 33 |
| 2017 | 0 | — | 2 | 12 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 1 | 22 |
| 2020 | 0 | — | 0 | 44 |
| 2021 | 0 | — | 0 | 63 |
| 2022 | 0 | — | 1 | 12 |
| 2023 | 0 | — | 1 | 43 |
| 2024 | 0 | — | 5 | 58 |
| 2025 | 0 | — | 1 | 33 |
| 2026 | 0 | — | 12 (1) | — |
https://510kreport.com/device/K874063 · printed Nov 6, 2026
Cite this page
510(k) Report. “K874063: Enteron Abdominal Paracentesis Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K874063
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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