510(k) Report

510(k) · Cleared

Cleared

Storc Intrauterine Pressure Catheter

K954955510(k) TraditionalCleared Apr 17, 1996173-day reviewClass II21 CFR 884.2700

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

Clinical Innovations, Inc. · HFN Transducer, Pressure, Intrauterine

Cleared on Apr 17, 1996 after a 173-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.

Decided
Apr 17, 1996
Review
173 days
Class
Class II
Product code
HFN
Recalls
None
Predicates
0

10 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2007: 1 descendant cleared2006: 1 descendant cleared2010: 2 descendants cleared2011: 2 descendants cleared2018: 1 descendant cleared2014: 1 descendant cleared2022: 1 descendant cleared1995200020052010201520202025
  1. This deviceK954955 Storc Intrauterine Pressure CatheterClinical Innovations, Inc. · 1996
  2. Descendant · cites it directly · 9 of its ownK052795 Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH · 2005 · Recalled
  3. Descendant · 2 generations on · 8 of its ownK062137 Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH · 2006 · Recalled
  4. Descendant · 2 generations on · 7 of its ownK071800 Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · Recalled
  5. Descendant · 3 generations on · 4 of its ownK100420 Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH · 2010
  6. Descendant · 2 generations on · 3 of its ownK092028 Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH · 2010

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12007: 12010: 22011: 22014: 12018: 12022: 1
2005high 2 (2010) · low 0 (2008)2026

Most influential descendants

Showing 5 of 10 · See all
  • K052795Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH · 2005 · cites it directly9descendants
  • K062137Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH · 2006 · 2 generations on8descendants
  • K071800Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · 2 generations on7descendants
  • K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH · 2010 · 3 generations on4descendants
  • K092028Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH · 2010 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954955Storc Intrauterine Pressure CatheterClinical Innovations, Inc.1996—
+1K052795Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH20051
+2K062137Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH20062
+2K071800Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20074
+3K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH2010—
+2K092028Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200710
201020
201120
201410
201810
202210
FIG. 1 — Lineage of K954955, 1996–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 HFN? 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 HFN device

  1. #1 K250897 Koala Intrauterine Pressure Catheter (IPC-5000E)score 9.4 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against? (4)

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
*—MX 4042 Series Intrauterine Pressure Catheter from Medex
Named without a submission number
—
*—Meditrace Disposable Intrauterine Catheter from Graphic Controls
Named without a submission number
—
*—Intrauterine Catheter from Telos
Named without a submission number
—
*—TUC - Intrauterine Catheter (INTRAN) from Utah Medical Products
Named without a submission number
—

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K052795Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH20059

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, K052795 (Philips Medizin Systeme Boeblingen GmbH, 2005) has gone furthest, with 9 descendants of its own.

How does its category compare?

All HFN devices

HFN Transducer, Pressure, Intrauterine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HFN

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HFN

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

Recalls per year · HFN

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HFN

4in 2024

2010: 12011: 42012: 12013: 12020: 22021: 32023: 12024: 4
2007high 4 (2011) · low 0 (2007)2025

MAUDE reports naming product code HFN, 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—00
20080—10
20090—00
20100—01
20110—04
20120—01
20130—01
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—02
20210—03
20220—00
20230—01
20240—04
20251—00
20260—0—

What is it indicated for?

This catheter is for use on patients requiring intrapartum, intrauterine pressure monitoring.

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

More from Clinical Innovations, Inc.

9 FDA decisions under this applicant name. See the company

  • K030691Fetal Spiral Electrode, Model FSE07000Clinical Innovations, Inc. · 20032 recalls
  • K022023Compass Esophageal Pressure Catheter, Model Gie-8500, Compass Ano-Rectal Pressure Catheter, Model Gia-8500Clinical Innovations, Inc. · 2003
  • K003458Soft Beat Fetal Heart Rate Electrode Model SBT-7000Clinical Innovations, Inc. · 2001
  • K981260Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom Cup with Palm Pump Model Vfe-6000MClinical Innovations, Inc. · 19982 recalls
  • K974563Colpo Cup CVC-2000Clinical Innovations, Inc. · 1998

Recent decisions in HFN

The HFN category page

  • K250897Koala Intrauterine Pressure Catheter (IPC-5000E)Clinical Innovations, LLC · 2025
  • K974389Koala Intrauterine Pressure Catheter, Koala External Intrauterine Pressure CatheterClinical Innovations, Inc. · 1998
  • K973746Pre-Filled Syringe for Koala IupClinical Innovations, Inc. · 1997
  • K961424Intran 500Utah Medical Products, Inc. · 19961 recall
  • K955443Intran PlusUtah Medical Products, Inc. · 19961 recall

https://510kreport.com/device/K954955 · printed Nov 6, 2026

Cite this page

510(k) Report. “K954955: Storc Intrauterine Pressure Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954955

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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