510(k) · Cleared
ClearedDobbhoff Anorect Biofeed Syst Five Div Fecal Const
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosearch Medical Products, Inc. · FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Cleared on Feb 7, 1992 after a 171-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Feb 7, 1992
- Review
- 171 days
- Class
- Class II
- Product code
- FAP
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK913736 Dobbhoff Anorect Biofeed Syst Five Div Fecal ConstBiosearch Medical Products, Inc. · 1992
- Descendant · cites it directly · 5 of its ownK014216 Secca SystemCuron Medical, Inc. · 2002
- Descendant · 2 generations on · 3 of its ownK110143 Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011
- Descendant · 3 generations on · 2 of its ownK121085 Het Bipolar Ligator SystemHet Systems, LLC · 2012
- Descendant · 4 generations on · 1 of its ownK140422 Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC · 2014
- Descendant · 5 generations on · 0 of its ownK200146 HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, LLC · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913736 | Dobbhoff Anorect Biofeed Syst Five Div Fecal Const | Biosearch Medical Products, Inc. | 1992 | — |
| +1 | K014216 | Secca System | Curon Medical, Inc. | 2002 | — |
| +2 | K110143 | Het Bipolar Electrocautery Forceps | Het Systems, LLC | 2011 | — |
| +3 | K121085 | Het Bipolar Ligator System | Het Systems, LLC | 2012 | — |
| +4 | K140422 | Het Systems, LLC, Het Bipolar Ligator System | Het Systems, LLC | 2014 | — |
| +5 | K200146 | HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor | Covidien, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
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
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? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 devicesFAP 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
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
MAUDE reports naming product code FAP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 36 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K913736 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913736: Dobbhoff Anorect Biofeed Syst Five Div Fecal Const.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913736
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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