510(k) · Cleared
ClearedBipolar Forceps, Kleppinger Insert, Model #'S 8393.741,8393.771,8394.741,8394.771
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · HIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Cleared on Apr 16, 1999 as substantially equivalent to K981321 (Richard Wolf Medical Instruments Corp., 1998) after an 87-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Apr 16, 1999
- Review
- 87 days
- Class
- Class II
- Product code
- HIN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981321 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK981321 Bipolar Forceps Set (Modular)Richard Wolf Medical Instruments Corp. · 1998
- This deviceK990147 Bipolar Forceps, Kleppinger Insert, Model #'S…Richard Wolf Medical Instruments Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981321 | Bipolar Forceps Set (Modular) | Richard Wolf Medical Instruments Corp. | 1998 | — |
| 0 (this device) | K990147 | Bipolar Forceps, Kleppinger Insert, Model #'S… | Richard Wolf Medical Instruments Corp. | 1999 | — |
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 HIN? 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981321 | Bipolar Forceps Set (Modular)Summary page 1…equivalence is clain 510¢k) Number |{ . Trade or proprietary or model name Manufacturer 1 pre-enact. 1 Kleppinger bipolar forceps 8383.21, 8384.21 1 Richard Wolf GmbH 2 K981321 2 Modular Bipolar Forcep Sets 8390/91/93/94 2 Richard Wolf Medical Instruments 1.0 Description The modular bipolar forcep set pr… | 1998 |
| * | — | Kleppinger bipolar forceps 8383.21, 8384.21 Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All HIN devicesHIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIN
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · HIN
Too few HIN 510(k)s in any year since 2007 to give a median.
Recalls per year · HIN
No recall names HIN since 2007.
Adverse event reports per year · HIN
43in 2025
MAUDE reports naming product code HIN, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 2 | — | 0 | 6 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 14 |
| 2014 | 1 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 29 |
| 2025 | 0 | — | 0 | 43 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The coagulation of tubes, tissue coagulation and vascular coagulation, and to stop bleedings under endoscopic vision, including coagulation of the fallopian tube and the mesoalpinx for female sterilization.
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/K990147 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990147: Bipolar Forceps, Kleppinger Insert, Model #'S 8393.741,8393.771,8394.741,8394.771.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990147
Report an extraction error
Are you the manufacturer?
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