510(k) Report

510(k) · Cleared

Cleared

Bipolar Forceps

K912544510(k) TraditionalCleared Jun 24, 199114-day reviewClass II21 CFR 870.1650

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

Everest Medical Corp. · MAV Syringe, Balloon Inflation

Cleared on Jun 24, 1991 after a 14-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 257 devices in its family, counting itself, has a Class I recall. 256 later devices descend from it.

Decided
Jun 24, 1991
Review
14 days
Class
Class II
Product code
MAV
Recalls
None
Predicates
0

256 later devices descend from it, 1 citing it directly. 1 of the 257 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1997: 1 descendant cleared1999: 2 descendants cleared1998: 1 descendant cleared2013: 7 descendants cleared2010: 1 descendant cleared2001: 2 descendants cleared2006: 3 descendants cleared2009: 2 descendants cleared2005: 2 descendants cleared2011: 5 descendants cleared2014: 10 descendants cleared2015: 6 descendants cleared2016: 11 descendants cleared2018: 18 descendants cleared2008: 5 descendants cleared2017: 14 descendants cleared2012: 4 descendants cleared2019: 9 descendants cleared2020: 17 descendants cleared2021: 18 descendants cleared2022: 18 descendants cleared2025: 33 descendants cleared2023: 22 descendants cleared, 1 with a Class I recall12026: 23 descendants cleared2024: 22 descendants cleared1990200020102020
  1. This deviceK912544 Bipolar ForcepsEverest Medical Corp. · 1991
  2. Descendant · cites it directly · 255 of its ownK972415 Minisite*Bipolar Forceps** DeviceUnited States Surgical, A Division of Tyco Healthc · 1997
  3. Descendant · 2 generations on · 234 of its ownK991859 Dexide Bipolar Forceps II ** DeviceUnited States Surgical, A Division of Tyco Healthc · 1999
  4. Descendant · 3 generations on · 233 of its ownK012833 Intuitive Surgical Bipolar ForcepsIntuitive Surgical, Inc. · 2001 · Recalled
  5. Descendant · 4 generations on · 229 of its ownK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
  6. Descendant · 4 generations on · 228 of its ownK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005

Showing 5 of 256 descendants. See all descendants

Descendants cleared per year

1997: 11998: 11999: 22001: 22005: 22006: 32008: 52009: 22010: 12011: 52012: 42013: 72014: 102015: 62016: 112017: 142018: 182019: 92020: 172021: 182022: 182023: 222024: 222025: 332026: 23
1997high 33 (2025) · low 0 (2000)2026

Class I recalls in this family

  • K223095 Senhance Surgical System6 generations on · 2023

Most influential descendants

Showing 5 of 256 · See all
  • K972415Minisite*Bipolar Forceps** DeviceUnited States Surgical, A Division of Tyco Healthc · 1997 · cites it directly255descendants
  • K991859Dexide Bipolar Forceps II ** DeviceUnited States Surgical, A Division of Tyco Healthc · 1999 · 2 generations on234descendants
  • K012833Intuitive Surgical Bipolar ForcepsIntuitive Surgical, Inc. · 2001 · 3 generations on233descendants
  • K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005 · 4 generations on229descendants
  • K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005 · 4 generations on228descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K912544Bipolar ForcepsEverest Medical Corp.1991—
+1K972415Minisite*Bipolar Forceps** DeviceUnited States Surgical, A Division of Tyco Healthc1997—
+2K991859Dexide Bipolar Forceps II ** DeviceUnited States Surgical, A Division of Tyco Healthc1999—
+3K012833Intuitive Surgical Bipolar ForcepsIntuitive Surgical, Inc.20014
+4K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005—
+4K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199920
200120
200520
200630
200850
200920
201010
201150
201240
201370
2014100
201560
2016110
2017140
2018180
201990
2020170
2021180
2022180
2023221
2024220
2025330
2026230
FIG. 1 — Lineage of K912544, 1991–2026Source: 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.

1 device in this family has a Class I recall. 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 MAV device

  1. #1 K260035 Digital Indeflator INFLANTEscore 12.6 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) 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? (256)

See all 256

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

NumberDeviceApplicantDecidedDescendants
K972415Minisite*Bipolar Forceps** DeviceUnited States Surgical, A Division of Tyco Healthc1997255

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · 6 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K972415 (United States Surgical, A Division of Tyco Healthc, 1997) has gone furthest, with 255 descendants of its own.

How does its category compare?

All MAV devices

MAV Syringe, Balloon Inflation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MAV

1in 2022

2008: 12011: 12012: 42013: 12014: 22015: 32016: 32022: 12026 (partial year): 1
2007high 4 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAV

69in 2016

2012: 85 days median2015: 116 days median2016: 69 days median
2007high 116 (2015) · low 69 (2016)2026

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

Recalls per year · MAV

4in 2024

2010: 32014: 22016: 12018: 12022: 52024: 4
2007high 5 (2022) · low 0 (2007)2026

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

Adverse event reports per year · MAV

66in 2025

2007: 372008: 502009: 992010: 882011: 942012: 2512013: 2452014: 922015: 1212016: 1242017: 2462018: 3002019: 1992020: 1012021: 1862022: 4372023: 2202024: 4202025: 66
2007high 437 (2022) · low 37 (2007)2025

MAUDE reports naming product code MAV, 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—037
20081—050
20090—099
20100—388
20111—094
20124850251
20131—0245
20142—292
201531160121
20163691124
20170—0246
20180—1300
20190—0199
20200—0101
20210—0186
20221—5437
20230—0220
20240—4420
20250—066
20261—0—

More from Everest Medical Corp.

21 FDA decisions under this applicant name. See the company

  • K003060Plasmakinetic GeneratorEverest Medical Corp. · 2000
  • K000496Evershears Bipolar ScissorsEverest Medical Corp. · 2000
  • K993412Bitx ProbesEverest Medical Corp. · 2000
  • K994336Bitx ProbesEverest Medical Corp. · 2000
  • K971565Bicoag Coagulating ForcepsEverest Medical Corp. · 1998

Recent decisions in MAV

The MAV category page

  • K260035Digital Indeflator INFLANTEUAB Telemedicina · 2026
  • K220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock…Medtronic Vascular · 2022
  • K162272Fluent inflation deviceVascular Solutions, Inc. · 2016
  • K153038Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device…Medtronic, Inc. · 2016
  • K153672basixTOUCH40 Inflation SyringeMerit Medical Systems, Inc. · 2016

https://510kreport.com/device/K912544 · printed Nov 6, 2026

Cite this page

510(k) Report. “K912544: Bipolar Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912544

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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