510(k) · Cleared
ClearedSemkin Insulated Bipolar Forcep
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Titan Mfg., Inc. · HTD Forceps
Cleared on Jun 24, 1998 after a 197-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Jun 24, 1998
- Review
- 197 days
- Class
- Class I
- Product code
- HTD
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK974593 Semkin Insulated Bipolar ForcepTitan Mfg., Inc. · 1998
- Descendant · cites it directly · 1 of its ownK213386 Titan Manufacturing Bipolar ForcepsTitan Manufacturing, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK230432 Single Use Bipolar ForcepsHg Innovations, Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974593 | Semkin Insulated Bipolar Forcep | Titan Mfg., Inc. | 1998 | — |
| +1 | K213386 | Titan Manufacturing Bipolar Forceps | Titan Manufacturing, Inc. | 2021 | 45 |
| +2 | K230432 | Single Use Bipolar Forceps | Hg Innovations, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HTD? 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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213386 | Titan Manufacturing Bipolar Forceps | 2021 | 1 |
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, K213386 (Titan Manufacturing, Inc., 2021) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HTD devicesHTD Forceps: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HTD
FDA has decided no HTD device since 2007.
Median 510(k) review, days · HTD
Too few HTD 510(k)s in any year since 2007 to give a median.
Recalls per year · HTD
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTD
119in 2025
MAUDE reports naming product code HTD, 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 | 0 | — | 4 | 15 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 0 | — | 2 | 24 |
| 2010 | 0 | — | 0 | 18 |
| 2011 | 0 | — | 0 | 28 |
| 2012 | 0 | — | 0 | 34 |
| 2013 | 0 | — | 2 | 245 |
| 2014 | 0 | — | 0 | 104 |
| 2015 | 0 | — | 0 | 109 |
| 2016 | 0 | — | 0 | 232 |
| 2017 | 0 | — | 0 | 99 |
| 2018 | 0 | — | 1 | 97 |
| 2019 | 0 | — | 1 | 132 |
| 2020 | 0 | — | 0 | 128 |
| 2021 | 0 | — | 0 | 156 |
| 2022 | 0 | — | 0 | 147 |
| 2023 | 0 | — | 0 | 155 |
| 2024 | 0 | — | 1 | 176 |
| 2025 | 0 | — | 0 | 119 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Intended to remove tissue and control bleeding by use of high frequency electrical current. (21 CFR §878.4400).
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974593 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974593: Semkin Insulated Bipolar Forcep.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974593
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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