510(k) Report

510(k) · Cleared

Cleared

Curity Suprapubic Drainage System

K842899510(k) TraditionalCleared Sep 10, 198449-day reviewClass U

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

The Kendal Co. · LJE Catheter, Nephrostomy

Cleared on Sep 10, 1984 after a 49-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 10, 1984
Review
49 days
Class
Class U
Product code
LJE
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared19801990200020102020
  1. This deviceK842899 Curity Suprapubic Drainage SystemThe Kendal Co. · 1984
  2. Descendant · cites it directly · 0 of its ownK970969 Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement SetThe Kendal Co. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K970969Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement SetThe Kendal Co. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K842899Curity Suprapubic Drainage SystemThe Kendal Co.1984—
+1K970969Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement SetThe Kendal Co.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K842899, 1984–1997Source: 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 LJE? 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 LJE device

  1. #1 K250448 Disposable Percutaneous Nephrostomy Dilatation…score 9.9 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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
K970969Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement SetThe Kendal Co.19970

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, K970969 (The Kendal Co., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LJE devices

LJE Catheter, Nephrostomy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LJE

1in 2025

2007: 12008: 12012: 12014: 12016: 12017: 12018: 32019: 42020: 22022: 12023: 12025: 1
2007high 4 (2019) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJE

254in 2019

2018: 107 days median2019: 254 days median
2007high 254 (2019) · low 107 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LJE

1in 2025

2007: 12016: 12019: 12020: 22021: 12025: 1
2007high 2 (2020) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LJE

59in 2025

2007: 52008: 82009: 122010: 62011: 152012: 162013: 152014: 42015: 92016: 262017: 602018: 692019: 782020: 502021: 382022: 422023: 1312024: 472025: 59
2007high 131 (2023) · low 4 (2014)2025

MAUDE reports naming product code LJE, 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
20071—15
20081—08
20090—012
20100—06
20110—015
20121—016
20130—015
20141—04
20150—09
20161—126
20171—060
20183107069
20194254178
20202—250
20210—138
20221—042
20231—0131
20240—047
20251—159
20260—0—

More from The Kendal Co.

63 FDA decisions under this applicant name. See the company

  • K000087Marhukar Triple Lumen Catheter, Model 12 FRThe Kendal Co. · 2000
  • K990500Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter Tray, Model 6946CThe Kendal Co. · 19991 Class I recall
  • K991758Monoject Insulin SyringeThe Kendal Co. · 1999
  • K970969Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement SetThe Kendal Co. · 1997
  • K951488Kendall Curity Catheter Plug with Protective CapThe Kendal Co. · 1995

Recent decisions in LJE

The LJE category page

  • K250448Disposable Percutaneous Nephrostomy Dilatation KitShenzhen Trious Medical Technology Co., Ltd. · 2025
  • K222705Introducer NeedleYoucare Technology Co.,Ltd. (Wuhan) · 2023
  • K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture…Coloplast Corp. · 2022
  • K201165In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathColoplast Corp. · 2020
  • K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with…Cook Incorporated · 2020

https://510kreport.com/device/K842899 · printed Nov 4, 2026

Cite this page

510(k) Report. “K842899: Curity Suprapubic Drainage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K842899

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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