510(k) Report

510(k) · Cleared

Cleared

Bci-100 Fecal Incontinence System

K904646510(k) TraditionalCleared Mar 19, 1991159-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

Biocare Intl. · FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

Cleared on Mar 19, 1991 after a 159-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
Mar 19, 1991
Review
159 days
Class
Class II
Product code
FAP
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2011: 2 descendants cleared2012: 1 descendant cleared2014: 1 descendant cleared2020: 1 descendant cleared1990200020102020
  1. This deviceK904646 Bci-100 Fecal Incontinence SystemBiocare Intl. · 1991
  2. Descendant · cites it directly · 5 of its ownK014216 Secca SystemCuron Medical, Inc. · 2002
  3. Descendant · 2 generations on · 3 of its ownK110143 Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011
  4. Descendant · 3 generations on · 2 of its ownK121085 Het Bipolar Ligator SystemHet Systems, LLC · 2012
  5. Descendant · 4 generations on · 1 of its ownK140422 Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC · 2014
  6. Descendant · 5 generations on · 0 of its ownK200146 HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, LLC · 2020

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2002: 12011: 22012: 12014: 12020: 1
2002high 2 (2011) · low 0 (2003)2026

Most influential descendants

Showing 5 of 6 · See all
  • K014216Secca SystemCuron Medical, Inc. · 2002 · cites it directly5descendants
  • K110143Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011 · 2 generations on3descendants
  • K121085Het Bipolar Ligator SystemHet Systems, LLC · 2012 · 3 generations on2descendants
  • K140422Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC · 2014 · 4 generations on1descendant
  • K200146HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, LLC · 2020 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K904646Bci-100 Fecal Incontinence SystemBiocare Intl.1991—
+1K014216Secca SystemCuron Medical, Inc.2002—
+2K110143Het Bipolar Electrocautery ForcepsHet Systems, LLC2011—
+3K121085Het Bipolar Ligator SystemHet Systems, LLC2012—
+4K140422Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC2014—
+5K200146HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, LLC2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
201120
201210
201410
202010
FIG. 1 — Lineage of K904646, 1991–2020Source: 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
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K014216Secca SystemCuron Medical, Inc.20025

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, K014216 (Curon Medical, Inc., 2002) has gone furthest, with 5 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—

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/K904646 · printed Nov 5, 2026

Cite this page

510(k) Report. “K904646: Bci-100 Fecal Incontinence System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K904646

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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