510(k) · Cleared
ClearedSCC-23 Safety Clamp and Cutter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Women First Healthcare, Inc. · KNA Instrument, Manual, Specialized Obstetric-Gynecologic
Cleared on Aug 11, 1998 as substantially equivalent to K963428 (R.O.S.T. Medical Development, Inc., 1997) after a 27-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Aug 11, 1998
- Review
- 27 days
- Class
- Class II
- Product code
- KNA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963428 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK963428 Umbilical Clamp and CutterR.O.S.T. Medical Development, Inc. · 1997
- This deviceK982464 SCC-23 Safety Clamp and CutterWomen First Healthcare, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK011621 Koala Clamp, Koala Clamp and CutterMaternus, Inc. · 2001
- Descendant · 2 generations on · 0 of its ownK152350 Regular and Special Umbilical Cord Clamp and CutterNingbo Feite Medical Device Co., Ltd. · 2016
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 |
|---|---|---|---|---|---|
| −1 | K963428 | Umbilical Clamp and Cutter | R.O.S.T. Medical Development, Inc. | 1997 | — |
| 0 (this device) | K982464 | SCC-23 Safety Clamp and Cutter | Women First Healthcare, Inc. | 1998 | — |
| +1 | K011621 | Koala Clamp, Koala Clamp and Cutter | Maternus, Inc. | 2001 | — |
| +2 | K152350 | Regular and Special Umbilical Cord Clamp and Cutter | Ningbo Feite Medical Device Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2016 | 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 KNA? 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? (1)
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 |
|---|---|---|---|
| * | K963428 | Umbilical Clamp and CutterSummary page 2…4530 U8 Kag 2y 6y /Lo — WOMEN FIRST HEALTHCARE 510(k) SUMMARY (Cont) Page2 of 2 PREDICATE DEVICE.: Veridien Corporation’s umbilical clamping shear, K963428 DESCRIPTION OF DEVICE: The SCC-23 Safety Clamp and Cutter is a pre-sterilized, ready-to-use, disposable obstetric instrument com… | 1997 |
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 |
|---|---|---|---|
| K011621 | Koala Clamp, Koala Clamp and Cutter | 2001 | 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?
- Its one ancestor has no recall.
- Of its descendants, K011621 (Maternus, Inc., 2001) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KNA devicesKNA Instrument, Manual, Specialized Obstetric-Gynecologic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNA
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · KNA
Too few KNA 510(k)s in any year since 2007 to give a median.
Recalls per year · KNA
No recall names KNA since 2007.
Adverse event reports per year · KNA
5in 2025
MAUDE reports naming product code KNA, 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 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 8 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 22 |
| 2017 | 0 | — | 0 | 37 |
| 2018 | 0 | — | 0 | 63 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The indications for use of the SCC-23 Safety Clamp and Cutter are to simultaneously clamp and cut the umbilical cord. The device reduces the risk to healthcare practitioners of unnecessary exposure to infection by bloodborne diseases.
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/K982464 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982464: SCC-23 Safety Clamp and Cutter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982464
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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