510(k) · Cleared
Recalled · Class II · 2022Titan Manufacturing Bipolar Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Titan Manufacturing, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 25, 2021 as substantially equivalent to K974593 (Titan Mfg., Inc., 1998) and 2 other predicates after a 12-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it. It has been recalled 45 times.
- Decided
- Oct 25, 2021
- Review
- 12 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 45
- Predicates
- 3
Its longest line of descent runs back 1 generation to K974593 (1998). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K230432Single Use Bipolar ForcepsHg Innovations, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974593 | Semkin Insulated Bipolar Forcep | Titan Mfg., Inc. | 1998 | — |
| 0 (this device) | K213386 | Titan Manufacturing Bipolar Forceps | Titan Manufacturing, Inc. | 2021 | — |
| +1 | K230432 | Single Use Bipolar Forceps | Hg Innovations, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
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 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K974593 | Semkin Insulated Bipolar ForcepSummary page 4…GEI Review Panel: General & Plastic Surgery Predicate Devices Product Name Manufacturer 510(k) # K974593 Semkin Insulated Bipolar Forcep Titan Manufacturing, Inc. K974594 Semkin Bipolar F… | 1998 |
| * | K974594 | Semkin Bipolar ForcepSummary page 4…duct Name Manufacturer 510(k) # K974593 Semkin Insulated Bipolar Forcep Titan Manufacturing, Inc. K974594 Semkin Bipolar Forcep Titan Manufacturing, Inc. K974595 Cushing Bayonet… | 1998 |
| * | K974595 | Cushing Bayonet, Insulated Bipolar ForcepSummary page 4…Insulated Bipolar Forcep Titan Manufacturing, Inc. K974594 Semkin Bipolar Forcep Titan Manufacturing, Inc. K974595 Cushing Bayonet Insulated Bipolar Forcep Titan Manufacturing, Inc. These predicates have not been subject… | 1998 |
| † | K121426 | Aynergetics Disposable Spetzler-Malis Standard Bipolar Forceps | 2012 |
| † | K182773 | Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230432 | Single Use Bipolar Forceps | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 2, 2022 | Class II | Z-0373-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0375-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0376-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0377-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0379-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0385-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0387-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0389-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0390-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0392-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0394-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0397-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0400-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0401-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0402-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0403-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0404-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0405-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0410-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0374-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0378-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0380-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0381-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0382-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0383-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0384-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0386-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0388-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0391-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0393-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0395-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0396-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0398-2023 | Under Investigation by firm | XXX |
| Nov 2, 2022 | Class II | Z-0399-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0406-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0415-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0407-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0408-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0411-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0416-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0417-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0409-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0412-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0413-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
| Nov 2, 2022 | Class II | Z-0414-2023 | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as… |
The 5 latest of 45 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- Of its descendants, K230432 (Hg Innovations, Ltd., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2007high 65 (2023) · low 35 (2011)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
2007high 183 (2026) · low 51 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
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
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
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
Titan Manufacturing Bipolar Forceps are intended to remove tissue and control bleeding by use of high frequency electrical current.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213386: Titan Manufacturing 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/K213386
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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