510(k) Report

510(k) · Cleared

Cleared

Electrodes

K944992510(k) TraditionalCleared Apr 27, 1995197-day reviewClass II21 CFR 878.4400

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

Linvatec Corp. · JOS Electrode, Electrosurgical

Cleared on Apr 27, 1995 after a 197-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 18 later devices descend from it.

Decided
Apr 27, 1995
Review
197 days
Class
Class II
Product code
JOS
Recalls
None
Predicates
0

18 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2000: 1 descendant cleared2021: 1 descendant cleared2008: 1 descendant cleared2015: 1 descendant cleared2003: 3 descendants cleared2005: 1 descendant cleared2010: 2 descendants cleared2004: 1 descendant cleared2006: 1 descendant cleared2009: 1 descendant cleared2018: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant cleared2023: 1 descendant cleared1995200020052010201520202025
  1. This deviceK944992 ElectrodesLinvatec Corp. · 1995
  2. Descendant · cites it directly · 10 of its ownK993655 Micro-France Electrosurgical Instruments, VariousXomed, Inc. · 1999 · Recalled
  3. Descendant · cites it directly · 6 of its ownK993885 Ultrablator ElectrodeLinvatec Corp. · 2000
  4. Descendant · 2 generations on · 4 of its ownK030720 Ultrablator ElectrodeLinvatec Corp. · 2003
  5. Descendant · 2 generations on · 3 of its ownK150959 Sutter Bipolar Forceps-CalvianSutter Medizintechnik GmbH · 2015
  6. Descendant · 3 generations on · 2 of its ownK172368 Bipolar Micro-Coagulation ForcepsGunter Bissinger Medizintechnik GmbH · 2018

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

1999: 12000: 12003: 32004: 12005: 12006: 12008: 12009: 12010: 22015: 12018: 12021: 12023: 12024: 12026: 1
1999high 3 (2003) · low 0 (2001)2026

Most influential descendants

Showing 5 of 18 · See all
  • K993655Micro-France Electrosurgical Instruments, VariousXomed, Inc. · 1999 · cites it directly10descendants
  • K993885Ultrablator ElectrodeLinvatec Corp. · 2000 · cites it directly6descendants
  • K030720Ultrablator ElectrodeLinvatec Corp. · 2003 · 2 generations on4descendants
  • K150959Sutter Bipolar Forceps-CalvianSutter Medizintechnik GmbH · 2015 · 2 generations on3descendants
  • K172368Bipolar Micro-Coagulation ForcepsGunter Bissinger Medizintechnik GmbH · 2018 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K944992ElectrodesLinvatec Corp.1995—
+1K993655Micro-France Electrosurgical Instruments, VariousXomed, Inc.19992
+1K993885Ultrablator ElectrodeLinvatec Corp.2000—
+2K030720Ultrablator ElectrodeLinvatec Corp.2003—
+2K150959Sutter Bipolar Forceps-CalvianSutter Medizintechnik GmbH2015—
+3K172368Bipolar Micro-Coagulation ForcepsGunter Bissinger Medizintechnik GmbH2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200330
200410
200510
200610
200810
200910
201020
201510
201810
202110
202310
202410
202610
FIG. 1 — Lineage of K944992, 1995–2026Source: 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 JOS? 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? (18)

See all 18

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K993655Micro-France Electrosurgical Instruments, VariousXomed, Inc.199910
K993885Ultrablator ElectrodeLinvatec Corp.20006

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, K993655 (Xomed, Inc., 1999) has gone furthest, with 10 descendants of its own.

How does its category compare?

All JOS devices

JOS Electrode, Electrosurgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOS

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOS

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

Recalls per year · JOS

2in 2019

2008: 12012: 22016: 12019: 2
2007high 2 (2012) · low 0 (2007)2026

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

Adverse event reports per year · JOS

6in 2025

2007: 292008: 372009: 622010: 142011: 52012: 72013: 52014: 72015: 132016: 62017: 72018: 102019: 172020: 122021: 52022: 82023: 92024: 32025: 6
2007high 62 (2009) · low 3 (2024)2025

MAUDE reports naming product code JOS, 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—029
20080—137
20090—062
20100—014
20110—05
20120—27
20130—05
20140—07
20150—013
20161—16
20170—07
20180—010
20190—217
20200—012
20210—05
20220—08
20230—09
20240—03
20250—06
20260—0—
Cite this page

510(k) Report. “K944992: Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944992

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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