510(k) · Cleared
ClearedValved Safety Centesis Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · GCB Needle, Catheter
Cleared on Nov 12, 2015 as substantially equivalent to K974146 (Allegiance Healthcare Corp., 1998) after a 231-day review. Its family tree reaches back 2 generations to 1987.
- Decided
- Nov 12, 2015
- Review
- 231 days
- Class
- Class I
- Product code
- GCB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K870704 (1987). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K974146 | Paracentesis Catheter DeviceSummary page 4…CFR 878.4200, Drainage Catheter, Class II Predicate Device: Paracentesis Catheter, Allegiance Healthcare Corporation, K974146 Reference device: Introcan Safety 3, B. Braun Medical Inc., K111236 Description: The Valved Safety Centesis Cat… | 1998 |
| † | K111236 | Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) /… | 2011 |
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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 17.8 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All GCB devicesGCB Needle, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 Valved Safety Centesis Catheter is indicated for the therapeutic or diagnostic aspiration of fluids from body cavities.
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/K150800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150800: Valved Safety Centesis Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150800
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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