510(k) Report

510(k) · Cleared

Recalled · Class II · 2010

Needle Elctrode

K944265510(k) TraditionalCleared May 5, 1995246-day reviewClass II21 CFR 878.4400Recalls 11

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

Unimed Surgical Products, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on May 5, 1995 after a 246-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled 11 times.

Decided
May 5, 1995
Review
246 days
Class
Class II
Product code
GEI
Recalls
11
Predicates
0

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

Descendants, by year cleared 2017: 1 descendant cleared1999: 1 descendant cleared1995200020052010201520202025
  1. This deviceK944265 Needle ElctrodeUnimed Surgical Products, Inc. · 1995
  2. Descendant · cites it directly · 0 of its ownK163442 Single Use Micro Electrode (Brass with gold plated shaft); Single…Modern Medical Equipment Manufacturing Limited · 2017
  3. Descendant · cites it directly · 0 of its ownK983852 Blue Value Line of Electrosurgical Electrodes, Model #'S 421-429Geiger Medical Technologies, Inc. · 1999

Most influential descendants

Showing 2 of 2 · See all
  • K163442Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode…Modern Medical Equipment Manufacturing Limited · 2017 · cites it directly0descendants
  • K983852Blue Value Line of Electrosurgical Electrodes, Model #'S 421-429Geiger Medical Technologies, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K944265Needle ElctrodeUnimed Surgical Products, Inc.1995—
+1K163442Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro…Modern Medical Equipment Manufacturing Limited2017—
+1K983852Blue Value Line of Electrosurgical Electrodes, Model #'S 421-429Geiger Medical Technologies, Inc.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
201710
FIG. 1 — Lineage of K944265, 1995–2017Source: 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 GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEI device

  1. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K163442Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode…Modern Medical Equipment Manufacturing Limited20170
K983852Blue Value Line of Electrosurgical Electrodes, Model #'S 421-429Geiger Medical Technologies, Inc.19990

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 16, 2010Class IIZ-2292-2012Process controlOn 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Jun 16, 2010Class IIZ-2286-2012Process controlOn 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Jun 16, 2010Class IIZ-2287-2012Process controlOn 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Jun 16, 2010Class IIZ-2296-2012Process controlOn 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Jun 16, 2010Class IIZ-2294-2012Process controlOn 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Jun 16, 2010Class IIZ-2288-2012Process controlOn 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Jun 16, 2010Class IIZ-2295-2012Process controlOn 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Jun 16, 2010Class IIZ-2290-2012Process controlOn 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Jun 16, 2010Class IIZ-2293-2012Process controlOn 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Jun 16, 2010Class IIZ-2289-2012Process controlOn 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Jun 16, 2010Class IIZ-2291-2012Process controlOn 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.

The 5 latest of 11 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K163442 (Modern Medical Equipment Manufacturing Limited, 2017) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

More from Unimed Surgical Products, Inc.

13 FDA decisions under this applicant name. See the company

  • K132224Unimed Surgical Coated Electrosurgical ElectrodesUnimed Surgical Products, Inc. · 2013
  • K993647Unimed Disposable Hand and Foot-Switching Pencils with Holster and 1BLADE and Tip Cleaner, Unimed Disposable…Unimed Surgical Products, Inc. · 1999
  • K970066Unimed Coated Laparoscopic/Arthroscopy/Suction-Irrigation ElectrodeUnimed Surgical Products, Inc. · 19971 recall
  • K963338Unimed Suction-Irrigation Electrode and Sliding SheathUnimed Surgical Products, Inc. · 1996
  • K962935Unimed Coated Needle Electrode/Coated Blade Electrode/Coated Ball ElectrodeUnimed Surgical Products, Inc. · 199613 recalls

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https://510kreport.com/device/K944265 · printed Nov 4, 2026

Cite this page

510(k) Report. “K944265: Needle Elctrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944265

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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