510(k) Report

510(k) · Cleared

Cleared

Cook® Spectrum® 2 MRC Central Venous Catheter

K223648510(k) TraditionalCleared Feb 3, 202359-day reviewClass II21 CFR 880.5200

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

Cook Advanced Technologies · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Cleared on Feb 3, 2023 as substantially equivalent to K081113 (Cook, Inc., 2008) after a 59-day review. Its family tree reaches back 5 generations to 1997. 1 later device descends from it.

Decided
Feb 3, 2023
Review
59 days
Class
Class II
Product code
FOZ
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K960764 (1997). 10 ancestors in all, the oldest K904404 (1991). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2001: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1991: 1 other ancestor2024: 1 descendant clearedReference device: K071538 · Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous Catheter · Arrow International, Inc. · 2007 · Class I recallK960764 · Safe-Cath · Scientific Device Manufacturer, LLC · 1997K984189 · Argon Multi-Lumen Central Venous Catheter · Maxxim Medical · 1999K032274 · Cook Five Lumen Central Venous Catheter · Cook, Inc. · 2004K060174 · Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-Abrm · Cook, Inc. · 2006K081113 · Cook and Cook Spectrum Central Venous Catheters · Cook, Inc. · 2008 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 4 other ancestors 1 generation forward: 1 descendant K081113 · Cook and Cook Spectrum Central Venous Catheters · Cook, Inc. · 2008 · recalledK060174 · Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-Abrm · Cook, Inc. · 2006K032274 · Cook Five Lumen Central Venous Catheter · Cook, Inc. · 2004K984189 · Argon Multi-Lumen Central Venous Catheter · Maxxim Medical · 1999K960764 · Safe-Cath · Scientific Device Manufacturer, LLC · 1997−50
  1. Root · 5 generations backK960764 Safe-CathScientific Device Manufacturer, LLC · 1997
  2. 4 generations backK984189 Argon Multi-Lumen Central Venous CatheterMaxxim Medical · 1999
  3. 3 generations backK032274 Cook Five Lumen Central Venous CatheterCook, Inc. · 2004
  4. 2 generations backK060174 Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-AbrmCook, Inc. · 2006
  5. 1 generation backK081113 Cook and Cook Spectrum Central Venous CathetersCook, Inc. · 2008 · Recalled
  6. This deviceK223648 Cook® Spectrum® 2 MRC Central Venous CatheterCook Advanced Technologies · 2023
  7. Descendant · cites it directly · 0 of its ownK241115 SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central…Spectrum Vascular · 2024

Most influential descendants

Showing 1 of 1 · See all
  • K241115SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV…Spectrum Vascular · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K960764Safe-CathScientific Device Manufacturer, LLC1997—
−4K984189Argon Multi-Lumen Central Venous CatheterMaxxim Medical1999—
−3K032274Cook Five Lumen Central Venous CatheterCook, Inc.2004—
−2K060174Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-AbrmCook, Inc.2006—
−1K081113Cook and Cook Spectrum Central Venous CathetersCook, Inc.2008105
0 (this device)K223648Cook® Spectrum® 2 MRC Central Venous CatheterCook Advanced Technologies2023—
+1K241115SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous…Spectrum Vascular2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199610
199710
200110
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
FIG. 1 — Lineage of K223648, 1997–2024Source: 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), 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 FOZ? 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 FOZ device

  1. #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 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? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K081113Cook and Cook Spectrum Central Venous Catheters
Summary page 4
…Intravascular Catheter Regulation Number: 21 CFR 880.5200 Product Code: FOZ Device Class: II Predicate Device: K081113, Cook® Spectrum®/Spectrum® Glide Central Venous Catheter Reference Device: K071538, ARROWg+…
Cook, Inc.2008105
†K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc.2007Class I

Also cleared against K081113: 2 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K241115SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV…Spectrum Vascular20240

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?

  • The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
  • 4 of the 10 ancestors have a recall of any class.
  • Of its descendants, K241115 (Spectrum Vascular, 2024) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K081113.

How does its category compare?

All FOZ devices

FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · FOZ

11in 2025

2007: 62008: 92009: 92010: 32011: 62012: 132013: 42014: 92015: 102016: 92017: 92018: 12019: 82020: 102021: 42022: 82023: 92024: 62025: 112026 (partial year): 7
2007high 13 (2012) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FOZ

91in 2025

2007: 159 days median2008: 103 days median2009: 30 days median2010: 28 days median2011: 132 days median2012: 122 days median2013: 104 days median2014: 99 days median2015: 107 days median2016: 63 days median2017: 51 days median2019: 140 days median2020: 191 days median2021: 242 days median2022: 183 days median2023: 129 days median2024: 190 days median2025: 91 days median2026 (partial year): 203 days median
2007high 242 (2021) · low 28 (2010)2026

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

Recalls per year · FOZ

4in 2023

2007: 162009: 232010: 1152013: 22014: 42016: 3, 1 Class I2017: 222018: 42019: 32020: 32021: 12022: 4, 2 Class I2023: 4, 2 Class I2026 (partial year): 2
2007high 115 (2010) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · FOZ

5,110in 2025

2007: 3742008: 4222009: 5082010: 3702011: 7862012: 5602013: 6402014: 8152015: 7292016: 9252017: 1,9662018: 3,3052019: 4,3652020: 3,7972021: 4,6742022: 4,1332023: 4,4302024: 4,7722025: 5,110
2007high 5,110 (2025) · low 370 (2010)2025

MAUDE reports naming product code FOZ, 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
2007615916374
200891030422
200993023508
2010328115370
201161320786
2012131220560
201341042640
20149994815
2015101070729
20169633 (1)925
2017951221,966
20181—43,305
2019814034,365
20201019133,797
2021424214,674
202281834 (2)4,133
202391294 (2)4,430
2024619004,772
2025119105,110
202672032—

What is it indicated for?

The Cook® Spectrum® 2 MRC Central Venous Catheter is indicated to provide short-term ( <30 days) central venous access intended for: • Continuous or intermittent drug infusion • Central venous blood pressure monitoring (CVP) • Acute hyperalimentation • Blood sampling • Delivery of whole blood or blood products • Simultaneous, separate infusion of drugs and • Power injection of contrast media (max 300 psi). The activity of the antimicrobial agents…

Read the full statement (166 words)

The Cook® Spectrum® 2 MRC Central Venous Catheter is indicated to provide short-term ( <30 days) central venous access intended for:

• Continuous or intermittent drug infusion

• Central venous blood pressure monitoring (CVP)

• Acute hyperalimentation

• Blood sampling

• Delivery of whole blood or blood products

• Simultaneous, separate infusion of drugs and

• Power injection of contrast media (max 300 psi).

The activity of the antimicrobial agents, minocycline, rifampin and chlorhexidine is located at the internal and external catheter surfaces and is not intended for treatment of existing infections. This combination of antimicrobials has been shown to reduce microbial colonization of the catheter. The effectiveness was evaluated using in vitro methods; no correlation between in vitro and clinical outcome has currently been ascertained. Controlled studies of this product have not been conducted in pregnant women, pediatric or neonatal patients. The benefits of the use of this catheter should be weighed against any possible risk. Consider CDC Guidelines and institutional protocols for catheter exchange.

Indications for use as stated in the FDA summary.

Also cleared against K081113

2 other devices cite the same predicate.

  • K182252Cook Unimpregnated Central Venous CatheterCook Incorporated · 2019
  • K101326NMI ICNavilyst Medical, Inc. · 2010

Recent decisions in FOZ

The FOZ category page

  • K260432Ruby Intravascular CatheterVenocare, Inc. · 2026
  • K260165Unimpregnated Central Venous CatheterSpectrum Vascular · 2026
  • K261041ClearSafe Closed SystemMedSource Labs, LLC · 2026
  • K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC · 2026
  • K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc. · 2026

https://510kreport.com/device/K223648 · printed Nov 6, 2026

Cite this page

510(k) Report. “K223648: Cook® Spectrum® 2 MRC Central Venous Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223648

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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