510(k) Report

510(k) · Decided

Decided

Curity Thoracentesis Tray

K903569510(k) TraditionalDecided Sep 7, 199031-day reviewClass II21 CFR 880.6740

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kendall Healthcare Products Co. Div.Of Tyco Health · JOL Catheter And Tip, Suction

Cleared on Sep 7, 1990 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Sep 7, 1990
Review
31 days
Class
Class II
Product code
JOL
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1990200020102020
  1. This deviceK903569 Curity Thoracentesis TrayKendall Healthcare Products Co. Div.Of Tyco Health · 1990
  2. Descendant · cites it directly · 0 of its ownK964519 Curity Thoracentesis TrayKendall Healthcare Products Co. Div.Of Tyco Health · 1996

Most influential descendants

Showing 1 of 1 · See all
  • K964519Curity Thoracentesis TrayKendall Healthcare Products Co. Div.Of Tyco Health · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K903569Curity Thoracentesis TrayKendall Healthcare Products Co. Div.Of Tyco Health1990—
+1K964519Curity Thoracentesis TrayKendall Healthcare Products Co. Div.Of Tyco Health1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K903569, 1990–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JOL? 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K964519Curity Thoracentesis TrayKendall Healthcare Products Co. Div.Of Tyco Health19960

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?

  • Of its descendants, K964519 (Kendall Healthcare Products Co. Div.Of Tyco Health, 1996) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JOL devices

JOL Catheter And Tip, Suction: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOL

FDA has decided no JOL device since 2007.

Median 510(k) review, days · JOL

Too few JOL 510(k)s in any year since 2007 to give a median.

Recalls per year · JOL

1in 2023

2012: 12019: 32023: 1, 1 Class I2026 (partial year): 1
2007high 3 (2019) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · JOL

277in 2025

2007: 172008: 142009: 172010: 252011: 172012: 252013: 342014: 422015: 272016: 612017: 1812018: 1612019: 4422020: 1872021: 2832022: 2212023: 1972024: 2772025: 277
2007high 442 (2019) · low 14 (2008)2025

MAUDE reports naming product code JOL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—017
20080—014
20090—017
20100—025
20110—017
20120—125
20130—034
20140—042
20150—027
20160—061
20170—0181
20180—0161
20190—3442
20200—0187
20210—0283
20220—0221
20230—1 (1)197
20240—0277
20250—0277
20260—1—
Cite this page

510(k) Report. “K903569: Curity Thoracentesis Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K903569

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026