510(k) Report

510(k) · Decided

Decided

BD Curve Ascites Shunt

K170405510(k) TraditionalDecided Nov 2, 2017265-day reviewClass II21 CFR 876.5955

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

Care Fusion · KPM Shunt, Peritoneal

Cleared on Nov 2, 2017 as substantially equivalent to K011862 (Denver Biomedical, Inc., 2001) and 2 other predicates after a 265-day review. Its family tree reaches back 6 generations to 1993.

Decided
Nov 2, 2017
Review
265 days
Class
Class II
Product code
KPM
Recalls
None
Predicates
3

Its longest line of descent runs back 6 generations to K932323 (1993). 16 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2013: 1 other ancestor2001: 1 other ancestor2012: 1 other ancestor2011: 1 other ancestor2008: 1 other ancestor2006: 1 other ancestor2005: 1 other ancestor2002: 1 other ancestor2000: 2 other ancestorsK932323 · Percutaneous Introducer · Medamicus, Inc. · 1993K021004 · Valved Peelable Introducer · Medamicus, Inc. · 2002K030905 · Medamicus Flowguard Peelable Introducer · Medamicus, Inc. · 2003K040150 · Modification to Medamicus Flowguard Peelable Introducer · Medamicus, Inc. · 2004K090394 · Valved Tearway Introducer · Medcomp · 2009K122422 · Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable Introducer · Care Fusion · 2012199019952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 3 other ancestors4 generations back: 2 other ancestors5 generations back: 1 other ancestor K122422 · Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable Introducer · Care Fusion · 2012K090394 · Valved Tearway Introducer · Medcomp · 2009K040150 · Modification to Medamicus Flowguard Peelable Introducer · Medamicus, Inc. · 2004K030905 · Medamicus Flowguard Peelable Introducer · Medamicus, Inc. · 2003K021004 · Valved Peelable Introducer · Medamicus, Inc. · 2002K932323 · Percutaneous Introducer · Medamicus, Inc. · 1993−50
  1. Root · 6 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
  2. 5 generations backK021004 Valved Peelable IntroducerMedamicus, Inc. · 2002
  3. 4 generations backK030905 Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2003
  4. 3 generations backK040150 Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2004
  5. 2 generations backK090394 Valved Tearway IntroducerMedcomp · 2009
  6. 1 generation backK122422 Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx…Care Fusion · 2012
  7. This deviceK170405 BD Curve Ascites ShuntCare Fusion · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K932323Percutaneous IntroducerMedamicus, Inc.1993—
−5K021004Valved Peelable IntroducerMedamicus, Inc.2002—
−4K030905Medamicus Flowguard Peelable IntroducerMedamicus, Inc.2003—
−3K040150Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc.2004—
−2K090394Valved Tearway IntroducerMedcomp2009—
−1K122422Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved…Care Fusion2012—
0 (this device)K170405BD Curve Ascites ShuntCare Fusion2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020
200110
200210
200510
200610
200810
201110
201210
201310
FIG. 1 — Lineage of K170405, 1993–2017Source: 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 KPM? 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 KPM device

  1. #1 K231096 Automatic Continuous Effusion Shunt (ACES)…score 5.9 · 1 generation · no Class I recall
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.

TypeNumberDeviceApplicantDecidedRecalls
*K011862Denver Ascites Shunt and Percutaneous Access Kit with Ascities Shunt
Summary page 4
…uct Code(s) KPM, DYB Denver Ascites Shunt And Percutaneous Access Kit With Ascites Shunt: Legally marketed device(s) to K011862 which equivalence is claimed Medcomp, Inc. – Valved Tearaway Introducer Generation II: K132498…
Denver Biomedical, Inc.2001—
*K132498Valved Tearaway Introducer Generation II
Summary page 4
…utaneous Access Kit With Ascites Shunt: Legally marketed device(s) to K011862 which equivalence is claimed Medcomp, Inc. – Valved Tearaway Introducer Generation II: K132498 CareFusion – Valved Peelable Introducers: K122422 This 510(k) sub…
Medcomp (Medical Components, Inc.)2013—
*K122422Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable…
Summary page 4
…ich equivalence is claimed Medcomp, Inc. – Valved Tearaway Introducer Generation II: K132498 CareFusion – Valved Peelable Introducers: K122422 This 510(k) submission is for minor design modifications to the Ascites…
Care Fusion2012—

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 24 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
  • 1 of the 16 ancestors has a recall of any class.

How does its category compare?

All KPM devices

KPM Shunt, Peritoneal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · KPM

1in 2023

2017: 12023: 1
2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPM

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

Recalls per year · KPM

No recall names KPM since 2007.

Adverse event reports per year · KPM

1in 2025

2007: 22008: 32009: 12010: 12011: 12012: 12013: 682014: 12017: 22022: 22023: 12024: 42025: 1
2007high 68 (2013) · low 0 (2015)2025

MAUDE reports naming product code KPM, 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—02
20080—03
20090—01
20100—01
20110—01
20120—01
20130—068
20140—01
20150—00
20160—00
20171—02
20180—00
20190—00
20200—00
20210—00
20220—02
20231—01
20240—04
20250—01
20260—0—

What is it indicated for?

Peritoneovenous shunting is indicated for patients with malignant or non-malignant intractable ascites (including patients with chylous ascites, hepatorenal syndrome, and idiopathic ascites), not responding to standard medical management, and not considered candidates for portal-venous shunting

The 17Fr valved peel-away introducer is intended for use in the percutaneous insertion of catheters in the peritoneal space.

The 15.5Fr Pigtail Revision Catheter is indicated for revising the peritoneal catheter of an BD Curve Ascites Shunt.

Indications for use as stated in the FDA summary.

More from Care Fusion

34 FDA decisions under this applicant name. See the company

  • K233021BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access DeviceCare Fusion · 2024
  • K231888BD Texium™ Needle-Free SyringeCare Fusion · 2023
  • K221327BD Alaris™ Pump Infusion SetsCare Fusion · 2023
  • K221319BD Alaris™ Pump Epidural Infusion SetCare Fusion · 2023
  • K223101BD Secondary Infusion SetCare Fusion · 2023

Recent decisions in KPM

The KPM category page

  • K231096Automatic Continuous Effusion Shunt (ACES) System ACES SystemPleural Dynamics, Inc. · 2023
  • K012235Denver Pleural Effusion Shunt and Denver Pleural Effusion Shunt with External Pump ChamberDenver Biomedical, Inc. · 2001
  • K011862Denver Ascites Shunt and Percutaneous Access Kit with Ascities ShuntDenver Biomedical, Inc. · 2001
  • K011020Denver Pleural Effusion Shunt with External Pump ChamberDenver Biomedicals, Inc. · 2001
  • K003451Denver Pak W/ Double-Valve Ascites Shunt,Denver Pak W/ Single-Valved Ascites Shunt, Denver Pak…Denver Biomedicals, Inc. · 2001

https://510kreport.com/device/K170405 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170405: BD Curve Ascites Shunt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170405

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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