510(k) Report

510(k) · Cleared

Cleared

Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry Catheter

K140129510(k) TraditionalCleared Jul 2, 2014167-day reviewClass II21 CFR 870.1230

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

Icu Medical, Inc. · DQE Catheter, Oximeter, Fiber-Optic

Cleared on Jul 2, 2014 as substantially equivalent to K061585 (Hospira, Inc., 2006) and 1 other predicate after a 167-day review. Its family tree reaches back 9 generations to 2000. 3 of the 31 devices in its family, counting itself, have a Class I recall.

Decided
Jul 2, 2014
Review
167 days
Class
Class II
Product code
DQE
Recalls
None
Predicates
2

Its longest line of descent runs back 9 generations to K001901 (2000). 30 ancestors in all, the oldest K820674 (1982). No later device cites it as a predicate yet. 3 of the 31 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year cleared 2006: 4 other ancestors2008: 1 other ancestor1997: 1 other ancestor1982: 1 other ancestor2004: 2 other ancestors2005: 3 other ancestors2003: 1 other ancestor2001: 2 other ancestors2000: 2 other ancestors, 1 with a Class I recall11999: 1 other ancestor1996: 1 other ancestor1983: 1 other ancestor1986: 1 other ancestor, 1 with a Class I recall1K001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalledK012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K033389 · Powerpicc Catheters, Models 3175155, 3175135 · C.R. Bard, Inc. · 2004 · recalled×3: 3 generations cleared close together, K050185 (2005), K051417 (2005), K051991 (2005) K080604 · Pressure Injfectable Picc · Arrow International, Inc. · 2008 · recalledK113277 · Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter Kits · Arrow International, Inc. · 2012 · Class I recall19801985199019952000200520102015
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 5 other ancestors3 generations back: 2 other ancestors4 generations back: 5 other ancestors5 generations back: 7 other ancestors, 1 with a Class I recall16 generations back: 1 other ancestor, 1 with a Class I recall1 K113277 · Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter Kits · Arrow International, Inc. · 2012 · Class I recallK080604 · Pressure Injfectable Picc · Arrow International, Inc. · 2008 · recalledK051991 · Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line · C.R. Bard, Inc. · 2005K051417 · 6 FR FL Powerhohn and Powerline Catheter · C.R. Bard, Inc. · 2005 · recalledK050185 · Powerhohn and Powerline Catheters · C.R. Bard, Inc. · 2005K033389 · Powerpicc Catheters, Models 3175155, 3175135 · C.R. Bard, Inc. · 2004 · recalledK031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalled−50
  1. Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 5 generations between
  3. 3 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
  4. 2 generations backK080604 Pressure Injfectable PiccArrow International, Inc. · 2008 · Recalled
  5. 1 generation backK113277 Arrowadvantages Pressure Injectable Peripherally Inscrted Central…Arrow International, Inc. · 2012 · Recalled (Class I)
  6. This deviceK140129 Piccox Peripherally Inserted Pressure Injectable, Central Venous…Icu Medical, Inc. · 2014
Show all 9 generations
  1. Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 8 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
  3. 7 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
  4. 6 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
  5. 5 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
  6. 4 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
  7. 3 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
  8. 2 generations backK080604 Pressure Injfectable PiccArrow International, Inc. · 2008 · Recalled
  9. 1 generation backK113277 Arrowadvantages Pressure Injectable Peripherally Inscrted Central…Arrow International, Inc. · 2012 · Recalled (Class I)
  10. This deviceK140129 Piccox Peripherally Inserted Pressure Injectable, Central Venous…Icu Medical, Inc. · 2014

Class I recalls in this family

  • K113277 Arrowadvantages Pressure Injectable Peripherally…direct predicate · 2012
  • K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…5 generations back · 2000
  • K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tip6 generations back · 1986
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K001901Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…C.R. Bard, Inc.20002
−8K012902Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…C.R. Bard, Inc.2001—
−7K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc.2003—
−6K033389Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc.20041
−5K050185Powerhohn and Powerline CathetersC.R. Bard, Inc.2005—
−4K0514176 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc.20051
−3K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc.2005—
−2K080604Pressure Injfectable PiccArrow International, Inc.20081
−1K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc.2012Class I
0 (this device)K140129Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry…Icu Medical, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
198310
198611
199610
199710
199910
200021
200120
200310
200420
200530
200640
200810
FIG. 1 — Lineage of K140129, 2000–2014Source: 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.

3 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.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (2)

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
*K061585Opticath Central Venous Oximetry Catheter
Summary page 1
…entral Venous Oximetry Catheter Classification Names: 21 CFR 870.1230. Fiberoptic Oximeter Catheter. Product Code: DQE Predicate Device: K061585 ICU Medical, Inc. Opticath Central Venous Oximetry Catheter (also known as TriOx SCVO 2 Centr…
Hospira, Inc.20061
*K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter Kits
Summary page 1
…c. Opticath Central Venous Oximetry Catheter (also known as TriOx SCVO 2 Central Venous Catheter) K113277 Teleflex ArrowADVANTAGE TMPressure Injectable P1CC Device Description: The Peripherally Inserted, Pressure Inject…
Arrow International, Inc.2012Class I

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (3 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.

  • K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc. · 2012 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
  • K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 5 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
  • K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 6 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
  • 17 of the 30 ancestors have a recall of any class; 3 have a Class I recall.

How does its category compare?

All DQE devices

DQE Catheter, Oximeter, Fiber-Optic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · DQE

1in 2018

2009: 12011: 12014: 12016: 12018: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQE

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

Recalls per year · DQE

No recall names DQE since 2007.

Adverse event reports per year · DQE

31in 2025

2007: 202008: 122009: 512010: 642011: 542012: 792013: 582014: 382015: 582016: 682017: 472018: 382019: 632020: 392021: 392022: 572023: 482024: 472025: 31
2007high 79 (2012) · low 12 (2008)2025

MAUDE reports naming product code DQE, 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—020
20080—012
20091—051
20100—064
20111—054
20120—079
20130—058
20141—038
20150—058
20161—068
20170—047
20181—038
20190—063
20200—039
20210—039
20220—057
20230—048
20240—047
20250—031
20260—0—

What is it indicated for?

The Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter (PICCOx), is indicated for access to the central venous system for continuous in vivo measurement of the oxyhemoglobin saturation of blood (ScvO2), intravenous therapy, blood sampling, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the PICCOx may not exceed 300 psi.

Indications for use as stated in the FDA summary.

More from Icu Medical, Inc.

66 FDA decisions under this applicant name. See the company

  • K252130LifeShield Infusion Safety Software SuiteIcu Medical, Inc. · 2026
  • K252006OTTO™ Disinfecting CapIcu Medical, Inc. · 2026
  • K251980ClaveQS™ BagIcu Medical, Inc. · 2026
  • K250616Clave™ Neutral-Displacement Needlefree ConnectorsIcu Medical, Inc. · 2025
  • K242117LifeShield Infusion Safety Software SuiteIcu Medical, Inc. · 20252 recalls

Recent decisions in DQE

The DQE category page

  • K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter…Edwards Lifescience, LLC · 20181 recall
  • K160645PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC · 2016
  • K110167Presep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin)Edwards Lifesciences, LLC · 2011
  • K091268Hospira Latex-Free Critical Care and Advanced Sensor CathetersHospira, Inc. · 20095 recalls
  • K062999Opticath Central Venous Oximetry Probe with Seal with HeparinHospira, Inc. · 2006

https://510kreport.com/device/K140129 · printed Nov 5, 2026

Cite this page

510(k) Report. “K140129: Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140129

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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