510(k) · Cleared
ClearedParacentesis Catheter Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allegiance Healthcare Corp. · GCB Needle, Catheter
Cleared on Jan 28, 1998 as substantially equivalent to K870704 (American Pharmaseal Div. Ahsc, 1987) after an 86-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.
- Decided
- Jan 28, 1998
- Review
- 86 days
- Class
- Class I
- Product code
- GCB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K870704 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK870704 Closed Paracentesis System W/Boasberg Catheter SetAmerican Pharmaseal Div. Ahsc · 1987
- This deviceK974146 Paracentesis Catheter DeviceAllegiance Healthcare Corp. · 1998
- Descendant · cites it directly · 0 of its ownK150800 Valved Safety Centesis CatheterB.Braun Medical, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K150800Valved Safety Centesis CatheterB.Braun Medical, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870704 | Closed Paracentesis System W/Boasberg Catheter Set | American Pharmaseal Div. Ahsc | 1987 | — |
| 0 (this device) | K974146 | Paracentesis Catheter Device | Allegiance Healthcare Corp. | 1998 | — |
| +1 | K150800 | Valved Safety Centesis Catheter | B.Braun Medical, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 GCB? 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 |
|---|---|---|---|
| * | K870704 | Closed Paracentesis System W/Boasberg Catheter SetSummary page 1…gan Road MP-WM McGaw Park, IL 60085 (847) 785-3311 October, 1997 Paracentesis Catheter Class |l per 21CFR § 878.4200, Needle, Catheter Paracentesis Catheter device, K870704 owned by Allegiance Healthcare Corporation The paracentesis “catheter over the needle” is comprised of a Radiopaque Polyurethane… | 1987 |
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 |
|---|---|---|---|
| K150800 | Valved Safety Centesis Catheter | 2015 | 0 |
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.
- Of its descendants, K150800 (B.Braun Medical, Inc., 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GCB devicesGCB Needle, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCB
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · GCB
Too few GCB 510(k)s in any year since 2007 to give a median.
Recalls per year · GCB
3in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GCB
16in 2025
MAUDE reports naming product code GCB, 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 | — | 0 | 7 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 8 |
| 2011 | 0 | — | 0 | 11 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 13 |
| 2014 | 0 | — | 3 | 11 |
| 2015 | 1 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 0 | — | 0 | 46 |
| 2020 | 0 | — | 0 | 72 |
| 2021 | 0 | — | 0 | 19 |
| 2022 | 0 | — | 0 | 23 |
| 2023 | 0 | — | 0 | 14 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The paracentesis catheter is a device used for the
therapeutic or diagnostic aspiration of fluid or air
from the abdominal cavity.
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/K974146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974146: Paracentesis Catheter Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974146
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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