510(k) Report

510(k) · Cleared

Cleared

Modified Quinton Single Lumen Catheter

K896252510(k) TraditionalCleared Jan 29, 199091-day reviewClass II21 CFR 876.5540

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

Quinton, Inc. · MPB Catheter, Hemodialysis, Non-Implanted

Cleared on Jan 29, 1990 after a 91-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
Jan 29, 1990
Review
91 days
Class
Class II
Product code
MPB
Recalls
None
Predicates
0

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

Descendants, by year cleared 2020: 1 descendant cleared1990200020102020
  1. This deviceK896252 Modified Quinton Single Lumen CatheterQuinton, Inc. · 1990
  2. Descendant · cites it directly · 0 of its ownK192302 Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen…Covidien, LLC · 2020 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute…Covidien, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K896252Modified Quinton Single Lumen CatheterQuinton, Inc.1990—
+1K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter…Covidien, LLC20206

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
FIG. 1 — Lineage of K896252, 1990–2020Source: 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 MPB? 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 MPB device

  1. #1 K250836 14F Duo-Flow® Side X Side Double Lumen Catheterscore 10.1 · 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
K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute…Covidien, LLC20200

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, K192302 (Covidien, LLC, 2020) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MPB devices

MPB Catheter, Hemodialysis, Non-Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MPB

1in 2025

2007: 32009: 12010: 12011: 22012: 12013: 12016: 12017: 22020: 32025: 1
2007high 3 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MPB

205in 2020

2007: 136 days median2020: 205 days median
2007high 205 (2020) · low 136 (2007)2026

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

Recalls per year · MPB

4so far in 2026, the most since 2007

2007: 12017: 22026 (partial year): 4, 3 Class I
2007high 4 (2026) · low 0 (2008)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · MPB

187in 2025

2007: 412008: 1472009: 1662010: 602011: 742012: 782013: 1242014: 822015: 512016: 702017: 862018: 1202019: 1192020: 1792021: 1922022: 1662023: 2032024: 1812025: 187
2007high 203 (2023) · low 41 (2007)2025

MAUDE reports naming product code MPB, 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
20073136141
20080—0147
20091—0166
20101—060
20112—074
20121—078
20131—0124
20140—082
20150—051
20161—070
20172—286
20180—0120
20190—0119
202032050179
20210—0192
20220—0166
20230—0203
20240—0181
20251—0187
20260—4 (3)—

More from Quinton, Inc.

164 FDA decisions under this applicant name. See the company

  • K032038Pyramis Ecg Management System Model Numbers, 92600 and 92601Quinton, Inc. · 2003
  • K021906Quinton Q-Cath, Model 000460Quinton, Inc. · 2002
  • K003576Q-Tel RMS (Rehabilitation Management System), Model 000503Quinton, Inc. · 20011 recall
  • K001492Quinton Q-Stress, Model 000483Quinton, Inc. · 2000
  • K992908Q-Tel Telemetry System V. 6.0 (ST)Quinton, Inc. · 2000

Recent decisions in MPB

The MPB category page

  • K25083614F Duo-Flow® Side X Side Double Lumen CatheterMedical Components, Inc. · 2025
  • K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International Corporation · 2020
  • K192807Duo-Flow Side x Side Double Lumen CatheterMedical Components, Inc. (dba MedComp) · 2020
  • K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen…Covidien, LLC · 20206 recalls
  • K163458Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2017

https://510kreport.com/device/K896252 · printed Nov 6, 2026

Cite this page

510(k) Report. “K896252: Modified Quinton Single Lumen Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K896252

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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