510(k) Report

510(k) · Cleared

Cleared

Spectrum Silicone Foley Catheter

K000251510(k) TraditionalCleared Aug 30, 2000216-day reviewClass II21 CFR 876.5130

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

Cook Urological, Inc. · MJC Catheter, Urological (Antimicrobial) And Accessories

Cleared on Aug 30, 2000 after a 216-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 of the 128 devices in its family, counting itself, have a Class I recall. 127 later devices descend from it.

Decided
Aug 30, 2000
Review
216 days
Class
Class II
Product code
MJC
Recalls
None
Predicates
0

127 later devices descend from it, 1 citing it directly. 15 of the 128 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2003: 1 descendant cleared2005: 1 descendant cleared2018: 9 descendants cleared2008: 2 descendants cleared2009: 6 descendants cleared2007: 4 descendants cleared, 1 with a Class I recall12010: 7 descendants cleared, 1 with a Class I recall12006: 2 descendants cleared2013: 14 descendants cleared, 2 with a Class I recall22020: 6 descendants cleared2011: 5 descendants cleared2016: 13 descendants cleared, 2 with a Class I recall22021: 1 descendant cleared, 1 with a Class I recall12014: 13 descendants cleared, 2 with a Class I recall22012: 16 descendants cleared, 3 with a Class I recall32015: 7 descendants cleared, 2 with a Class I recall22022: 3 descendants cleared, 1 with a Class I recall12025: 6 descendants cleared2019: 4 descendants cleared2023: 3 descendants cleared2017: 4 descendants cleared200020052010201520202025
  1. This deviceK000251 Spectrum Silicone Foley CatheterCook Urological, Inc. · 2000
  2. Descendant · cites it directly · 126 of its ownK021557 Spectrum Silicone CatheterCook, Inc. · 2003
  3. Descendant · 2 generations on · 119 of its ownK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
  4. Descendant · 3 generations on · 66 of its ownK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
  5. Descendant · 3 generations on · 47 of its ownK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
  6. Descendant · 4 generations on · 29 of its ownK091953 Pro-PiccMedcomp · 2009

Showing 5 of 127 descendants. See all descendants

Descendants cleared per year

2003: 12005: 12006: 22007: 42008: 22009: 62010: 72011: 52012: 162013: 142014: 132015: 72016: 132017: 42018: 92019: 42020: 62021: 12022: 32023: 32025: 6
2003high 16 (2012) · low 0 (2004)2026

Class I recalls in this family

  • K071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus…4 generations on · 2007
  • K210264 BD PowerPiCC Catheter4 generations on · 2021
  • K113277 Arrowadvantages Pressure Injectable Peripherally…4 generations on · 2012
  • K143102 Multi-Lumen Acute Hemodialysis Catheter for High…4 generations on · 2015

Most influential descendants

Showing 5 of 127 · See all
  • K021557Spectrum Silicone CatheterCook, Inc. · 2003 · cites it directly126descendants
  • K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc. · 2005 · 2 generations on119descendants
  • K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007 · 3 generations on66descendants
  • K061179Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006 · 3 generations on47descendants
  • K091953Pro-PiccMedcomp · 2009 · 4 generations on29descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000251Spectrum Silicone Foley CatheterCook Urological, Inc.2000—
+1K021557Spectrum Silicone CatheterCook, Inc.2003—
+2K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc.2005—
+3K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc.2007—
+3K061179Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc.2006—
+4K091953Pro-PiccMedcomp2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200620
200741
200820
200960
201071
201150
2012163
2013142
2014132
201572
2016132
201740
201890
201940
202060
202111
202231
202330
202560
FIG. 1 — Lineage of K000251, 2000–2025Source: 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.

15 devices in this family have a Class I recall. 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 MJC device

  1. #1 K233094 Wellead® Latex Foley Catheterscore 11.1 · 3 generations · no Class I recall
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? (127)

See all 127

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

NumberDeviceApplicantDecidedDescendants
K021557Spectrum Silicone CatheterCook, Inc.2003126

Has anything in its family been recalled? (15 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 15 Class I recalls
  • K210264BD PowerPiCC CatheterBard Access Systems, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
  • K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
  • K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
  • K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
  • K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 125 Class I recalls
  • K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
  • K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
  • K141531Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc. · 2015 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
  • K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
  • K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 6 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
  • K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 7 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall

Nearest 12 of 15 shown.

Nearest 5 of 15; all are on the web page.

What does this lineage say?

  • Of its descendants, K021557 (Cook, Inc., 2003) has gone furthest, with 126 descendants of its own.

How does its category compare?

All MJC devices

MJC Catheter, Urological (Antimicrobial) And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MJC

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MJC

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

Recalls per year · MJC

2in 2018

2015: 12016: 12018: 22026 (partial year): 1
2007high 2 (2018) · low 0 (2007)2026

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

Adverse event reports per year · MJC

3,747in 2025

2009: 22010: 12012: 52013: 82014: 132015: 252016: 1342017: 7142018: 6132019: 1,2702020: 1,4332021: 1,4642022: 1,7962023: 1,9872024: 1,9602025: 3,747
2007high 3,747 (2025) · low 0 (2007)2025

MAUDE reports naming product code MJC, 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—00
20080—00
20090—02
20100—01
20110—00
20120—05
20130—08
20140—013
20150—125
20160—1134
20170—0714
20180—2613
20190—01,270
20200—01,433
20210—01,464
20220—01,796
20230—01,987
20241—01,960
20250—03,747
20260—1—

More from Cook Urological, Inc.

104 FDA decisions under this applicant name. See the company

  • K102141Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)Cook Urological, Inc. · 2011
  • K0917673 Way Silicone Foley Balloon CatheterCook Urological, Inc. · 2009
  • K082939Cook Fetal Membrane Manipulator, Model -FMM-122400Cook Urological, Inc. · 2009
  • K082066Tao Brush I.U.M.C. Endometrial SamplerCook Urological, Inc. · 20081 recall
  • K082536Cook Wire GuidesCook Urological, Inc. · 20087 recalls

Recent decisions in MJC

The MJC category page

  • K233094Wellead® Latex Foley CatheterWell Lead Medical (Hainan) Co., Ltd. · 2024
  • K040658Bardex I.C. Latex Foley CatheterC.R. Bard, Inc. · 20049 recalls
  • K033477Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System KitRochester Medical Corp. · 20043 recalls
  • K001143Release NF Antibacterial Foley Catheter, Antibacterial Personal CatheterRochester Medical Corp. · 2000
  • K993464Bardex I.C. Pediatric Foley CatheterC.R. Bard, Inc. · 1999

https://510kreport.com/device/K000251 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000251: Spectrum Silicone Foley Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000251

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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