510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps

K080187510(k) TraditionalCleared May 9, 2008105-day reviewClass II21 CFR 878.4400Recalls 1

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

Olsen Medical · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on May 9, 2008 as substantially equivalent to K002752 (Q2 Medical, 2000) and 1 other predicate after a 105-day review. Its family tree reaches back 1 generation to 1988. 13 later devices descend from it. It has been recalled once.

Decided
May 9, 2008
Review
105 days
Class
Class II
Product code
GEI
Recalls
1
Predicates
2

Its longest line of descent runs back 1 generation to K884656 (1988). 2 ancestors in all. 13 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2019: 1 descendant cleared2011: 2 descendants cleared2022: 1 descendant cleared2012: 2 descendants cleared2023: 2 descendants cleared2020: 2 descendants cleared2024: 1 descendant cleared2016: 2 descendants clearedK884656 · Disposable Bipolar Cord and Bipolar Forcep · Dermacare · 1988 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant K884656 · Disposable Bipolar Cord and Bipolar Forcep · Dermacare · 1988 · recalled0
  1. Root · 1 generation backK884656 Disposable Bipolar Cord and Bipolar ForcepDermacare · 1988 · Recalled
  2. This deviceK080187 Olsen Medical Single Use Bayonet Bipolar Irrigating ForcepsOlsen Medical · 2008
  3. Descendant · cites it directly · 8 of its ownK110924 Disposable Spetzler-Malis Dual Irrigating Bipolar ForcepsSynergetics, Inc. · 2011 · Recalled
  4. Descendant · 2 generations on · 7 of its ownK121426 Aynergetics Disposable Spetzler-Malis Standard Bipolar ForcepsSynergetics, Inc. · 2012 · Recalled
  5. Descendant · cites it directly · 2 of its ownK182773 Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick…Faulhaber Pinzetten Ohg · 2019
  6. Descendant · 3 generations on · 2 of its ownK162469 CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps…Medos International SARL · 2016
  7. Descendant · 2 generations on · 1 of its ownK191847 Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt…Adeor Medical AG · 2020

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2011: 22012: 22016: 22019: 12020: 22022: 12023: 22024: 1
2011high 2 (2011) · low 0 (2013)2026

Most influential descendants

Showing 5 of 13 · See all
  • K110924Disposable Spetzler-Malis Dual Irrigating Bipolar ForcepsSynergetics, Inc. · 2011 · cites it directly8descendants
  • K121426Aynergetics Disposable Spetzler-Malis Standard Bipolar ForcepsSynergetics, Inc. · 2012 · 2 generations on7descendants
  • K182773Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating…Faulhaber Pinzetten Ohg · 2019 · cites it directly2descendants
  • K162469CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim…Medos International SARL · 2016 · 3 generations on2descendants
  • K191847Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick…Adeor Medical AG · 2020 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K884656Disposable Bipolar Cord and Bipolar ForcepDermacare19881
0 (this device)K080187Olsen Medical Single Use Bayonet Bipolar Irrigating ForcepsOlsen Medical2008—
+1K110924Disposable Spetzler-Malis Dual Irrigating Bipolar ForcepsSynergetics, Inc.20113
+2K121426Aynergetics Disposable Spetzler-Malis Standard Bipolar ForcepsSynergetics, Inc.201219
+1K182773Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar…Faulhaber Pinzetten Ohg2019—
+3K162469CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru…Medos International SARL2016—
+2K191847Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use…Adeor Medical AG2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201220
201620
201910
202020
202210
202320
202410
FIG. 1 — Lineage of K080187, 1988–2024Source: 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), the FDA summary (predicates and indications), 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
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K002752Bayonet Forceps Bipolar Irrigating
Summary page 1
…ivalence: Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps are substantially equivalent to Q2 Medical's Bayonet Forceps Bipolar Irrigating (K002752) and Dermacare's Disposable Bipolar Cord and Bipolar Forceps (K884656) based on the device's similarity to the predicated d…
Q2 Medical2000—
*K884656Disposable Bipolar Cord and Bipolar Forcep
Summary page 1
…are substantially equivalent to Q2 Medical's Bayonet Forceps Bipolar Irrigating (K002752) and Dermacare's Disposable Bipolar Cord and Bipolar Forceps (K884656) based on the device's similarity to the predicated device in intended use, materials, design, and functionality. Both of t…
Dermacare19881

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K110924Disposable Spetzler-Malis Dual Irrigating Bipolar ForcepsSynergetics, Inc.20118
K182773Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating…Faulhaber Pinzetten Ohg20192
K102752Stingray Ultralite Disposable Irrigating Bipolar ForcepsStingray Surgical Products, Inc.20110

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

Recalls of this device

DateClassRecallRoot causeReason
May 11, 2018Class IIZ-1945-2018Package design/selectionProducts may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K110924 (Synergetics, Inc., 2011) has gone furthest, with 8 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. 2008, this device’s year, is highlighted.

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—

What is it indicated for?

The Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps (Catalog No. 20-OXXX) is a single use product sold sterile and is intended for use in electrosurgery for coagulation and irrigation of tissue. This device is intended for use with the OLSEN MEDICAL Integrated Irrigation Tubing and Bipolar Cord Set or similar design of Bipolar Cord and Irrigation Tubing.

Indications for use as stated in the FDA summary.

More from Olsen Medical

5 FDA decisions under this applicant name. See the company

  • K130669Single Use & Multi Use Bipolar Forceps / Single Use & Multi Use Monopolar ForcepsOlsen Medical · 20131 recall
  • K111262Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/ Adapters, Bipolar Electrosurgical…Olsen Medical · 20122 recalls
  • K072937Olsen Medical Integrated Irrigation Tubing and Bipolar Cord SetOlsen Medical · 2007
  • K042073Olsen Medical Anterior Cervical Vertebrae Plate SystemOlsen Medical · 2005

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https://510kreport.com/device/K080187 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080187: Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080187

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026