510(k) · Cleared
ClearedCurity Thoracentesis Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kendall Healthcare Products Co. Div.Of Tyco Health · GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Cleared on Dec 20, 1996 as substantially equivalent to K903569 (Kendall Healthcare Products Co. Div.Of Tyco Health, 1990) and 2 other predicates after a 38-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Dec 20, 1996
- Review
- 38 days
- Class
- Class II
- Product code
- GCX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K870572 (1987). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK870572 Arrow-Clarke (TM) Pleura-Seal (TM) Thoracentesis KitArrow Intl., Inc. · 1987 · Recalled
- This deviceK964519 Curity Thoracentesis TrayKendall Healthcare Products Co. Div.Of Tyco Health · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870572 | Arrow-Clarke (TM) Pleura-Seal (TM) Thoracentesis Kit | Arrow Intl., Inc. | 1987 | 2 |
| 0 (this device) | K964519 | Curity Thoracentesis Tray | Kendall Healthcare Products Co. Div.Of Tyco Health | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 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.
Planning a device in GCX? 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? (3)
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 |
|---|---|---|---|
| * | K903569 | Curity Thoracentesis Tray Our OCR of the scanned summary read K503569, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Kendall Curity Thoracentesis Tray”. | 1990 |
| * | K870572 | Arrow-Clarke (TM) Pleura-Seal (TM) Thoracentesis KitSummary page 1…ction and composition to the commercially available Kendall Curity Thoracentesis Tray, 510(k) No. KS03569; Arrow International Pleura-Seal™ Thoracentesis Kit, 510(k) No. K870572; and Sherwood Medical Argyle® Turkel™ Safety Thoracentesis Procedure Tray, 510(k) No. K930847. 4 Device Description The propose… | 1987 |
| * | K930847 | Argyle Turkel Safety Thoracentesis Proc. TraySummary page 1…No. KS03569; Arrow International Pleura-Seal™ Thoracentesis Kit, 510(k) No. K870572; and Sherwood Medical Argyle® Turkel™ Safety Thoracentesis Procedure Tray, 510(k) No. K930847. 4 Device Description The proposed Kendall Curity Thoracentesis Tray is a sterile, single use procedural tray containing the co… | 1993 |
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?
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All GCX devicesGCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCX
FDA has decided no GCX device since 2007.
Median 510(k) review, days · GCX
Too few GCX 510(k)s in any year since 2007 to give a median.
Recalls per year · GCX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GCX
274in 2025
MAUDE reports naming product code GCX, 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 | 24 |
| 2008 | 0 | — | 0 | 44 |
| 2009 | 0 | — | 0 | 40 |
| 2010 | 0 | — | 0 | 51 |
| 2011 | 0 | — | 0 | 67 |
| 2012 | 0 | — | 0 | 242 |
| 2013 | 0 | — | 1 | 47 |
| 2014 | 0 | — | 0 | 32 |
| 2015 | 0 | — | 0 | 52 |
| 2016 | 0 | — | 0 | 99 |
| 2017 | 0 | — | 1 | 45 |
| 2018 | 0 | — | 0 | 50 |
| 2019 | 0 | — | 0 | 65 |
| 2020 | 0 | — | 0 | 65 |
| 2021 | 0 | — | 0 | 65 |
| 2022 | 0 | — | 0 | 72 |
| 2023 | 0 | — | 3 | 59 |
| 2024 | 0 | — | 1 | 65 |
| 2025 | 0 | — | 0 | 274 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
The Kendall Curity Thoracentesis Tray is intended to be used to drain fluid from the pleural 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/K964519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964519: Curity Thoracentesis Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964519
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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