510(k) Report

510(k) · Cleared

Cleared

Denver (R) Peritoneo-Subclavian Shunt

K913728510(k) TraditionalCleared Feb 18, 1994913-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

Denver Biomedicals, Inc. · KPM Shunt, Peritoneal

Cleared on Feb 18, 1994 after a 913-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Feb 18, 1994
Review
913 days
Class
Class II
Product code
KPM
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared1990200020102020
  1. This deviceK913728 Denver (R) Peritoneo-Subclavian ShuntDenver Biomedicals, Inc. · 1994
  2. Descendant · cites it directly · 0 of its ownK973129 Denver Ascites Shunts, Denver Ascites Shunt Percutaneous Access KitsDenver Biomaterials, Inc. · 1998

Most influential descendants

Showing 1 of 1 · See all
  • K973129Denver Ascites Shunts, Denver Ascites Shunt Percutaneous Access KitsDenver Biomaterials, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K913728Denver (R) Peritoneo-Subclavian ShuntDenver Biomedicals, Inc.1994—
+1K973129Denver Ascites Shunts, Denver Ascites Shunt Percutaneous Access KitsDenver Biomaterials, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K913728, 1994–1998Source: 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K973129Denver Ascites Shunts, Denver Ascites Shunt Percutaneous Access KitsDenver Biomaterials, Inc.19980

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?

  • Of its descendants, K973129 (Denver Biomaterials, Inc., 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KPM devices

KPM Shunt, Peritoneal: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

More from Denver Biomedicals, Inc.

10 FDA decisions under this applicant name. See the company

  • K051084Denver Pleurx Drainage Kit and Denver Pleurx Vacuum Bottle with Drainage LineDenver Biomedicals, Inc. · 2005
  • K011020Denver Pleural Effusion Shunt with External Pump ChamberDenver Biomedicals, Inc. · 2001
  • K010642Pleurx Pleural Catheter and Drainage KitsDenver Biomedicals, Inc. · 2001
  • K003451Denver Pak W/ Double-Valve Ascites Shunt,Denver Pak W/ Single-Valved Ascites Shunt, Denver Pak…Denver Biomedicals, Inc. · 2001
  • K943968TunnelerDenver Biomedicals, Inc. · 1995

Recent decisions in KPM

The KPM category page

  • K231096Automatic Continuous Effusion Shunt (ACES) System ACES SystemPleural Dynamics, Inc. · 2023
  • K170405BD Curve Ascites ShuntCare Fusion · 2017
  • 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

https://510kreport.com/device/K913728 · printed Nov 6, 2026

Cite this page

510(k) Report. “K913728: Denver (R) Peritoneo-Subclavian Shunt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913728

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026