510(k) Report

510(k) · Cleared

Cleared

Unimpregnated Central Venous Catheter

K260165510(k) TraditionalCleared Aug 10, 2026202-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

Spectrum Vascular · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Cleared on Aug 10, 2026 as substantially equivalent to K182252 (Cook Incorporated, 2019) after a 202-day review. Its family tree reaches back 6 generations to 1997.

Decided
Aug 10, 2026
Review
202 days
Class
Class II
Product code
FOZ
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K960764 (1997). 11 ancestors in all, the oldest K904404 (1991). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor2001: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1991: 1 other ancestorK960764 · 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 · recalledK182252 · Cook Unimpregnated Central Venous Catheter · Cook Incorporated · 20191990200020102020
Other ancestors, by generation 3 generations back: 1 other ancestor4 generations back: 4 other ancestors K182252 · Cook Unimpregnated Central Venous Catheter · Cook Incorporated · 2019K081113 · 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 · 6 generations backK960764 Safe-CathScientific Device Manufacturer, LLC · 1997
  2. 5 generations backK984189 Argon Multi-Lumen Central Venous CatheterMaxxim Medical · 1999
  3. 4 generations backK032274 Cook Five Lumen Central Venous CatheterCook, Inc. · 2004
  4. 3 generations backK060174 Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-AbrmCook, Inc. · 2006
  5. 2 generations backK081113 Cook and Cook Spectrum Central Venous CathetersCook, Inc. · 2008 · Recalled
  6. 1 generation backK182252 Cook Unimpregnated Central Venous CatheterCook Incorporated · 2019
  7. This deviceK260165 Unimpregnated Central Venous CatheterSpectrum Vascular · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K960764Safe-CathScientific Device Manufacturer, LLC1997—
−5K984189Argon Multi-Lumen Central Venous CatheterMaxxim Medical1999—
−4K032274Cook Five Lumen Central Venous CatheterCook, Inc.2004—
−3K060174Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-AbrmCook, Inc.2006—
−2K081113Cook and Cook Spectrum Central Venous CathetersCook, Inc.2008105
−1K182252Cook Unimpregnated Central Venous CatheterCook Incorporated2019—
0 (this device)K260165Unimpregnated Central Venous CatheterSpectrum Vascular2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199610
199710
200110
200410
FIG. 1 — Lineage of K260165, 1997–2026Source: 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
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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
*K182252Cook Unimpregnated Central Venous Catheter
Summary page 5
…Class II 5. PREDICATE DEVICE INFORMATION Predicate Device Name: Cook Unimpregnated Central Venous Catheter 510(k) Number: K182252 Manufacturer: Cook Incorporated…
Cook Incorporated2019—

What descends from it?

No later submission names this one as a predicate yet.

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 29 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
  • 4 of the 11 ancestors have a recall of any class.

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. 2026, 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 Unimpregnated Central Venous Catheter (Non-Power Injectable) is used for: 1. Continuous or intermittent drug infusions 2. Central venous blood pressure monitoring (CVP) 3. Acute hyperalimentation 4. Blood sampling 5. Delivery of whole blood or blood products 6. Simultaneous, separate infusion of drugs for multi-lumen catheters only The device is a short-term use catheter, intended for less than 30 days. The Cook dilator is used for dilating puncture…

Read the full statement (257 words)

The Unimpregnated Central Venous Catheter (Non-Power Injectable) is used for:

1. Continuous or intermittent drug infusions

2. Central venous blood pressure monitoring (CVP)

3. Acute hyperalimentation

4. Blood sampling

5. Delivery of whole blood or blood products

6. Simultaneous, separate infusion of drugs for multi-lumen catheters only

The device is a short-term use catheter, intended for less than 30 days.

The Cook dilator is used for dilating puncture sites or catheter tracts.

The Unimpregnated Central Venous Catheter (Non-Power Injectable) is intended for adult and pediatric populations.

The Unimpregnated Central Venous Catheter with Power Injection is used for:

1. Continuous or intermittent drug infusions

2. Central venous blood pressure monitoring (CVP)

3. Acute hyperalimentation

4. Blood sampling

5. Delivery of whole blood or blood products

6. Simultaneous, separate infusion of drugs for multi-lumen catheters only

7. Power injection of contrast media*

*The flow rate may not exceed 3 mL/sec for 4.0 and 5.0 French catheters and 10 mL/sec for 7.0, 8.0, 9.0 and 10.0 French catheters. Verify prior to use that the maximum safety cut-off pressure limit is set at or below 250 psi for 4.0 and 5.0 French catheters and 325 psi for 7.0, 8.0, 9.0 and 10.0 French catheters.

The device is a short-term use catheter, intended for less than 30 days.

The 9.0 and 10.0 French catheters include an inner catheter to facilitate insertion of the main catheter.

The Cook dilator is used for dilating puncture sites or catheter tracts.

The Unimpregnated Central Venous Catheter with power injection is intended for adult and pediatric populations.

Indications for use as stated in the FDA summary.

More from Spectrum Vascular

6 FDA decisions under this applicant name. See the company

  • K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and…Spectrum Vascular · 2025
  • K250724Intraosseous Infusion NeedlesSpectrum Vascular · 2025
  • K241115SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous CatheterSpectrum Vascular · 2024

Recent decisions in FOZ

The FOZ category page

  • K260432Ruby Intravascular CatheterVenocare, Inc. · 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
  • K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc. · 2026

https://510kreport.com/device/K260165 · printed Nov 4, 2026

Cite this page

510(k) Report. “K260165: Unimpregnated Central Venous Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260165

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026