510(k) · Cleared
ClearedQuick-Tap Paracentesis Tray, Kit & Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ballard Medical Products · LRO General Surgery Tray
Cleared on Mar 31, 2003 as substantially equivalent to K950574 (Tri-Med Specialties, Inc., 1995) and 1 other predicate after a 24-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Mar 31, 2003
- Review
- 24 days
- Class
- Class II
- Product code
- LRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K950574 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK950574 Needle/CannulaTri-Med Specialties, Inc. · 1995
- This deviceK030721 Quick-Tap Paracentesis Tray, Kit & NeedleBallard Medical Products · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950574 | Needle/Cannula | Tri-Med Specialties, Inc. | 1995 | — |
| 0 (this device) | K030721 | Quick-Tap Paracentesis Tray, Kit & Needle | Ballard Medical Products | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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.
Planning a device in LRO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LRO device
- #1 K212258 Medline Cardiovascular Procedure Kitscore 2.4 · 1 generation · no Class I recall
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.
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All LRO devicesLRO General Surgery Tray: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LRO
Too few LRO 510(k)s in any year since 2007 to give a median.
Recalls per year · LRO
14in 2025
Class I (93 since 2007) Class II/III not classified
Adverse event reports per year · LRO
5,488in 2025
MAUDE reports naming product code LRO, 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 | 8 |
| 2008 | 0 | — | 0 | 8 |
| 2009 | 0 | — | 2 | 5 |
| 2010 | 0 | — | 1 | 23 |
| 2011 | 0 | — | 11 | 17 |
| 2012 | 0 | — | 4 | 64 |
| 2013 | 0 | — | 11 (11) | 25 |
| 2014 | 0 | — | 59 (58) | 59 |
| 2015 | 0 | — | 5 | 628 |
| 2016 | 0 | — | 4 | 805 |
| 2017 | 0 | — | 29 | 523 |
| 2018 | 0 | — | 31 | 384 |
| 2019 | 0 | — | 4 | 406 |
| 2020 | 0 | — | 3 | 767 |
| 2021 | 1 | — | 3 | 920 |
| 2022 | 1 | — | 192 | 1,134 |
| 2023 | 0 | — | 18 (2) | 1,913 |
| 2024 | 0 | — | 60 (1) | 3,031 |
| 2025 | 0 | — | 14 (5) | 5,488 |
| 2026 | 0 | — | 75 (16) | — |
What is it indicated for?
The Quick-Tap@ Paracentesis Kit, Tray and Needle are indicated to relieve pressure by draining fluid from the peritoneal space. The fluid may be undergo diagnostic testing to assess for chemistries, infection or abnormal cells.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030721: Quick-Tap Paracentesis Tray, Kit & Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030721
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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