510(k) · Cleared

Cleared

Urethane Picc Line Model Upics-

K992198510(k) SpecialCleared Aug 27, 199958-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 Aug 27, 1999 as substantially equivalent to K862056 (Arrow Intl., Inc., 1986) after a 58-day review. Its family tree reaches back 1 generation to 1986. 16 of the 138 devices in its family, counting itself, have a Class I recall. 136 later devices descend from it.

Decided: Aug 27, 1999
Review: 58 days
Class: Class II
Product code: FOZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K862056 (1986). 136 later devices descend from it, 2 citing it directly. 16 of the 138 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK862056 [Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · Recalled (Class I)
This deviceK992198 Urethane Picc Line Model Upics-Cook, Inc. · 1999
Descendant · cites it directly · 126 of its ownK021557 Spectrum Silicone CatheterCook, Inc. · 2003
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
Descendant · 3 generations on · 66 of its ownK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
Descendant · 3 generations on · 47 of its ownK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
Descendant · 4 generations on · 29 of its ownK091953 Pro-PiccMedcomp · 2009

Showing 5 of 136 descendants. See all descendants

Descendants cleared per year

2003high 17 (2012) · low 0 (2004)2026

Class I recalls in this family

K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tipdirect predicate · 1986
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

Most influential descendants

Showing 5 of 136 · 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

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	2	0
2006	2	0
2007	4	1
2008	3	0
2009	7	0
2010	8	1
2011	5	0
2012	17	3
2013	14	2
2014	13	2
2015	7	2
2016	14	2
2017	4	0
2018	10	0
2019	5	0
2020	6	0
2021	2	1
2022	3	1
2023	3	0
2025	6	0

FIG. 1 — Lineage of K992198, 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.

16 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? (3)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K862056	[Central Venous][Multi-Lumen] Catheter W/Flex Tip Summary page 2 …r, 6 Fr, and 7 Fr and in lengths ranging from 50 to 60 cm. Peripherally Inserted Central Catheters (Arrow International) were reviewed as substantially equivalent under K862056 and are indicated for venous access to the central circulation through a peripheral vein for an alternative method of intravenous…	Arrow Intl., Inc.	1986	Class I
*	—	Silicone PICC Lines (COOK® Inc.) Named without a submission number			—
*	—	Vaxcel™ PICC Lines (Boston Scientific/Medi-Tech®) Named without a submission number			—

Also cleared against K862056: 2 other devices →

What descends from it? (136)

See all 136

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

Number	Device	Applicant	Decided	Descendants
K021557	Spectrum Silicone Catheter	Cook, Inc.	2003	126
K041849	Turbo-Flo Picc	Cook, Inc.	2005	8

Has anything in its family been recalled? (16 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.

K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · Direct predicate · ◆ 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 · 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

Nearest 12 of 16 shown.

Nearest 5 of 16; all are on the web page.

What does this lineage say?

Its one ancestor has a recall, Class I.
Of its descendants, K021557 (Cook, Inc., 2003) has gone furthest, with 126 descendants of its own.
2 other devices also cite its predicate K862056.

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?

Used for venous pressure monitoring, blood sampling and administration of drugs and fluids.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K992198 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992198: Urethane Picc Line Model Upics-.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992198

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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