510(k) · Cleared
ClearedDenver Paracentesis Needle (60-1200) Denver Paracentesis Needle with Drainage Line (60-1100) Denver Paracentesis Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Denver Biomaterials, Inc. · KDD Kit, Surgical Instrument, Disposable
Cleared on Apr 1, 1996 as substantially equivalent to K874063 (Endovations, 1987) and 1 other predicate after a 62-day review. Its family tree reaches back 1 generation to 1987. 1 of the 3 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 1, 1996
- Review
- 62 days
- Class
- Class I
- Product code
- KDD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K874063 (1987). 2 ancestors in all. No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK874063 Enteron Abdominal Paracentesis TrayEndovations · 1987 · Recalled (Class I)
- This deviceK960456 Denver Paracentesis Needle (60-1200) Denver Paracentesis Needle with…Denver Biomaterials, Inc. · 1996
Class I recalls in this family
- K874063 Enteron Abdominal Paracentesis Traydirect predicate · 1987
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874063 | Enteron Abdominal Paracentesis Tray | Endovations | 1987 | Class I |
| 0 (this device) | K960456 | Denver Paracentesis Needle (60-1200) Denver Paracentesis Needle with Drainage… | Denver Biomaterials, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
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.
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? (2)
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 |
|---|---|---|---|
| * | K874063 | Enteron Abdominal Paracentesis TraySummary page 1…ALENT DEVICE(S) The Denver® Paracentesis Needle, Paracentesis Needle with Drainage Line, and Paracentesis Tray are substantially equivalent in intended use to the i i (K874063). The Denver® and Endovations devices are similar in that they are both single-use, sterile devices used for draining fluid from… | 1987 |
| * | K932652 | Tri-Med Paracentesis TraySummary page 1…edle, Paracentesis Needle with Drainage Line, and Paracentesis Tray are also substantially equivalent in intended use to the Tri-Med Specialtieg, Inc. Paracentegis Tray (K932652). The Denver® and Tri-Med devices are similar in that they are both single-use, sterile devices used for draining fluid from the… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K874063Enteron Abdominal Paracentesis TrayEndovations · 1987 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
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) | — |
What is it indicated for?
The Denver® Paracentesis Needle, Paracentesis Needle with Drainage Line, and Paracentesis Tray are indicated for use in removing fluid from the peritoneal cavity (abdominal paracentesis). They are intended to be used for both diagnostic and therapeutic abdominal paracentesis procedures.
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/K960456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960456: Denver Paracentesis Needle (60-1200) Denver Paracentesis Needle with Drainage Line (60-1100) Denver 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/K960456
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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