510(k) Report

510(k) · Cleared

Cleared

Profile Plus Urodynamics Measuring Syst, Modified

K920992510(k) TraditionalCleared Apr 10, 199256-day reviewClass II21 CFR 876.1620

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

Browne Medical Systems, Inc. · FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

Cleared on Apr 10, 1992 after a 56-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
Apr 10, 1992
Review
56 days
Class
Class II
Product code
FAP
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared1990200020102020
  1. This deviceK920992 Profile Plus Urodynamics Measuring Syst, ModifiedBrowne Medical Systems, Inc. · 1992
  2. Descendant · cites it directly · 0 of its ownK970595 Circon Endotek OM-4 H2O Cystometry PumpCircon Video · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K970595Circon Endotek OM-4 H2O Cystometry PumpCircon Video · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K920992Profile Plus Urodynamics Measuring Syst, ModifiedBrowne Medical Systems, Inc.1992—
+1K970595Circon Endotek OM-4 H2O Cystometry PumpCircon Video1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K920992, 1992–1997Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FAP? 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
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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
K970595Circon Endotek OM-4 H2O Cystometry PumpCircon Video19970

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, K970595 (Circon Video, 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FAP devices

FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FAP

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FAP

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

Recalls per year · FAP

No recall names FAP since 2007.

Adverse event reports per year · FAP

36in 2025

2009: 12016: 12018: 22024: 22025: 36
2007high 36 (2025) · low 0 (2007)2025

MAUDE reports naming product code FAP, 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—00
20090—01
20100—00
20110—00
20121—00
20130—00
20140—00
20150—00
20160—01
20170—00
20180—02
20190—00
20200—00
20210—00
20220—00
20230—00
20240—02
20250—036
20260—0—

More from Browne Medical Systems, Inc.

7 FDA decisions under this applicant name. See the company

  • K921047Model 8100 Urodynamics Measuring SystemBrowne Medical Systems, Inc. · 1992
  • K920991Image Pro Urodynamics Measuring Syst, ModificationBrowne Medical Systems, Inc. · 1992
  • K910444Browne Medical Systems ImageproBrowne Medical Systems, Inc. · 1991
  • K910371Urodynamic Measuring SystemBrowne Medical Systems, Inc. · 1991
  • K910217Minipro 8100 Urodynamic Measureing SystemBrowne Medical Systems, Inc. · 1991

Recent decisions in FAP

The FAP category page

  • K113771Signal Gear Urethral Catheter ElectrodeNeurovision Medical Products, Inc. · 20122 recalls
  • K974775Single Channel Urological Pressure Gauge, Dual Channel Urological Pressure GaugeAirtronic Services, Inc. · 1998
  • K963330Urodynamic Analysis ModuleSynectics Medical, Inc. · 1997
  • K962472Rusch Urodynamic Rectal Balloon 2-Way CatheterRusch Intl. · 19961 recall
  • K931175Schuster Disposable Balloon ProbeSandhill Scientific, Inc. · 19942 recalls

https://510kreport.com/device/K920992 · printed Nov 3, 2026

Cite this page

510(k) Report. “K920992: Profile Plus Urodynamics Measuring Syst, Modified.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K920992

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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