510(k) Report

510(k) · Cleared

Cleared

Acmi Bipolar Hemostatic Electrode

K803214510(k) TraditionalCleared Jan 15, 198128-day reviewClass II21 CFR 876.4300

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

American Cystocope Makers, Inc. · FEH Electrode, Flexible Suction Coagulator

Cleared on Jan 15, 1981 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jan 15, 1981
Review
28 days
Class
Class II
Product code
FEH
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2011: 1 descendant cleared2010: 1 descendant cleared19801990200020102020
  1. This deviceK803214 Acmi Bipolar Hemostatic ElectrodeAmerican Cystocope Makers, Inc. · 1981
  2. Descendant · cites it directly · 2 of its ownK012018 Bicap Coag Bipolar Laparoscopy Probe, Model 006908-910Acmi Corporation · 2002
  3. Descendant · 2 generations on · 0 of its ownK102275 Thermedx 37-5 Electrocautery Probes, Models MPJ200, MPJ210, MPS220…Thermedx, LLC · 2011
  4. Descendant · 2 generations on · 0 of its ownK101711 Ceruleau Electrosurgical ProbeNuortho Surgical, Inc. · 2010

Most influential descendants

Showing 3 of 3 · See all
  • K012018Bicap Coag Bipolar Laparoscopy Probe, Model 006908-910Acmi Corporation · 2002 · cites it directly2descendants
  • K102275Thermedx 37-5 Electrocautery Probes, Models MPJ200, MPJ210, MPS220, MPN230, BPH240Thermedx, LLC · 2011 · 2 generations on0descendants
  • K101711Ceruleau Electrosurgical ProbeNuortho Surgical, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K803214Acmi Bipolar Hemostatic ElectrodeAmerican Cystocope Makers, Inc.1981—
+1K012018Bicap Coag Bipolar Laparoscopy Probe, Model 006908-910Acmi Corporation2002—
+2K102275Thermedx 37-5 Electrocautery Probes, Models MPJ200, MPJ210, MPS220, MPN230…Thermedx, LLC2011—
+2K101711Ceruleau Electrosurgical ProbeNuortho Surgical, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
201010
201110
FIG. 1 — Lineage of K803214, 1981–2011Source: 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 FEH? 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K012018Bicap Coag Bipolar Laparoscopy Probe, Model 006908-910Acmi Corporation20022

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, K012018 (Acmi Corporation, 2002) has gone furthest, with 2 descendants of its own.

How does its category compare?

All FEH devices

FEH Electrode, Flexible Suction Coagulator: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FEH

1in 2013

2012: 12013: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FEH

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

Recalls per year · FEH

No recall names FEH since 2007.

Adverse event reports per year · FEH

1in 2021

2007: 22013: 12017: 22018: 12020: 12021: 1
2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code FEH, 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—00
20090—00
20100—00
20110—00
20121—00
20131—01
20140—00
20150—00
20160—00
20170—02
20180—01
20190—00
20200—01
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—

More from American Cystocope Makers, Inc.

9 FDA decisions under this applicant name. See the company

  • K832040Sterile Fluid Producing Unit #EP550American Cystocope Makers, Inc. · 1983
  • K812637Acmi Bipolar Hemostatic SourceAmerican Cystocope Makers, Inc. · 1981
  • K811218Acmi Aspirator Kit #8808American Cystocope Makers, Inc. · 1981
  • K791182Acmi Rigi-Flex NephorscopeAmerican Cystocope Makers, Inc. · 1979
  • K770754Duodenoscope, Molel TX-6American Cystocope Makers, Inc. · 1977

Recent decisions in FEH

The FEH category page

  • K130489Electrode, Flexible Suction CoagulatorOptim, LLC · 2013
  • K122593Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use Disposable Maxi-Guide Flexible Lightguide…Optim, LLC · 2012

https://510kreport.com/device/K803214 · printed Nov 6, 2026

Cite this page

510(k) Report. “K803214: Acmi Bipolar Hemostatic Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K803214

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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