510(k) · Cleared

Cleared

Spectrum Silicone Catheter

K021557510(k) TraditionalCleared May 30, 2003382-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, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Cleared on May 30, 2003 as substantially equivalent to K992198 (Cook, Inc., 1999) and 5 other predicates after a 382-day review. Its family tree reaches back 2 generations to 1986. 17 of the 134 devices in its family, counting itself, have a Class I recall. 126 later devices descend from it.

Decided: May 30, 2003
Review: 382 days
Class: Class II
Product code: FOZ
Recalls: None
Predicates: 7

Its longest line of descent runs back 2 generations to K862056 (1986). 7 ancestors in all. 126 later devices descend from it, 4 citing it directly. 17 of the 134 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK862056 [Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · Recalled (Class I)
1 generation backK992198 Urethane Picc Line Model Upics-Cook, Inc. · 1999
This deviceK021557 Spectrum Silicone CatheterCook, Inc. · 2003
Descendant · cites it directly · 119 of its ownK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
Descendant · 2 generations on · 66 of its ownK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
Descendant · 2 generations on · 47 of its ownK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
Descendant · 3 generations on · 29 of its ownK091953 Pro-PiccMedcomp · 2009
Descendant · 2 generations on · 26 of its ownK101326 NMI ICNavilyst Medical, Inc. · 2010

Showing 5 of 126 descendants. See all descendants

Descendants cleared per year

2005high 16 (2012) · low 0 (2024)2026

Class I recalls in this family

K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…direct predicate · 2000
K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tip2 generations back · 1986
K071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus…3 generations on · 2007
K210264 BD PowerPiCC Catheter3 generations on · 2021

Most influential descendants

Showing 5 of 126 · See all

K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc. · 2005 · cites it directly119descendants
K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007 · 2 generations on66descendants
K061179Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006 · 2 generations on47descendants
K091953Pro-PiccMedcomp · 2009 · 3 generations on29descendants
K101326NMI ICNavilyst Medical, Inc. · 2010 · 2 generations on26descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K862056	[Central Venous][Multi-Lumen] Catheter W/Flex Tip	Arrow Intl., Inc.	1986	Class I
−1	K992198	Urethane Picc Line Model Upics-	Cook, Inc.	1999	—
0 (this device)	K021557	Spectrum Silicone Catheter	Cook, Inc.	2003	—
+1	K051991	Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line	C.R. Bard, Inc.	2005	—
+2	K070996	4 FR Single Lumen (SL) Powerpicc Catheter	C.R. Bard, Inc.	2007	—
+2	K061179	Powerhickman Long-Term Intravascular Catheter	C.R. Bard, Inc.	2006	—
+3	K091953	Pro-Picc	Medcomp	2009	—
+2	K101326	NMI IC	Navilyst Medical, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2000	2	1
2001	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	2	0
2007	4	1
2008	2	0
2009	6	0
2010	7	1
2011	5	0
2012	16	3
2013	14	2
2014	13	2
2015	7	2
2016	13	2
2017	4	0
2018	9	0
2019	4	0
2020	6	0
2021	1	1
2022	3	1
2023	3	0
2025	6	0

FIG. 1 — Lineage of K021557, 1986–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

17 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 FOZ device

#1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (7)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K013605	Silicone Catheter Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
*	K992198	Urethane Picc Line Model Upics- Summary page 2 …OOK Incorporated Silicone Catheter A1 37605 COOK IncorPorated Single Lumen Urethane PICC K992 198 COOK Incorporated Double Lumen Urethane PICC KO10034 COOK Incomorated SDectrum@…	Cook, Inc.	1999	—
*	K010034	Double Lumen Urethane Picc Line, Model Upicds-	Cook, Inc.	2001	—
*	K950118	Abrm Catheter Summary page 2 …COOK Incorporated Double Lumen Urethane PICC KO10034 COOK Incomorated SDectrum@Catheter K950118 COOK Incorporated SpectrumwVentricular Catheter KO11812 COOK UrologicaVOB/GYN Spectrum@…	Cook, Inc.	1996	1
*	K011812	Spectrum Ventricular Catheter	Cook, Inc.	2001	1
*	K000251	Spectrum Silicone Foley Catheter	Cook Urological, Inc.	2000	—
*	K993691	Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous Catheter Summary page 2 …OOK UrologicaVOB/GYN Spectrum@Silicone Foley Catheter KO0025 1 Arrow International, Inc. ARROWgard Blue PlusTMMulti-Lumen CVC K993691 Substantial Equivalence: The device will be manufactured according to specified process controls, adhering to Good Manufacturin…	Arrow Intl., Inc.	2000	Class I

Also cleared against K992198: 1 other device →

What descends from it? (126)

See all 126

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K051991	Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line	C.R. Bard, Inc.	2005	119
K172885	HydroPICC	Access Vascular, Inc.	2018	5
K081690	Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter	Cook, Inc.	2008	4
K171994	Silicone Peripherally Inserted Central Venous Catheter Set/Tray	Cook Incorporated	2018	0

Has anything in its family been recalled? (17 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.

K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · Direct predicate · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 15 Class I recalls
K210264BD PowerPiCC CatheterBard Access Systems, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc. · 2012 · 3 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 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · 3 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 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 125 Class I recalls
K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 4 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 · 4 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 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall

Nearest 12 of 17 shown.

Nearest 5 of 17; all are on the web page.

What does this lineage say?

The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 13.0 years on median.
4 of the 7 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K051991 (C.R. Bard, Inc., 2005) has gone furthest, with 119 descendants of its own.
1 other device also cites its predicate K992198.

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.

FDA decisions per year · FOZ

11in 2025

2007high 13 (2012) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FOZ

91in 2025

2007high 242 (2021) · low 28 (2010)2026

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

Recalls per year · FOZ

4in 2023

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	159	16	374
2008	9	103	0	422
2009	9	30	23	508
2010	3	28	115	370
2011	6	132	0	786
2012	13	122	0	560
2013	4	104	2	640
2014	9	99	4	815
2015	10	107	0	729
2016	9	63	3 (1)	925
2017	9	51	22	1,966
2018	1	—	4	3,305
2019	8	140	3	4,365
2020	10	191	3	3,797
2021	4	242	1	4,674
2022	8	183	4 (2)	4,133
2023	9	129	4 (2)	4,430
2024	6	190	0	4,772
2025	11	91	0	5,110
2026	7	203	2	—

What is it indicated for?

The COOK Spectrum®Silicone Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSI). It is not intended to be used as a treatment for existing infections. Catheters are available in single and double lumen PICC; and single, double and triple lumen CVC. The device is supplied sterile and intended for one-time use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021557 · printed Nov 5, 2026

Cite this page

510(k) Report. “K021557: Spectrum Silicone Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021557

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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