510(k) · Cleared
ClearedSecurline Umbilical Cord Clamp Clipper #3540
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Dynamics Corp. · HFW Clamp, Umbilical
Cleared on Jan 24, 2000 after a 38-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Jan 24, 2000
- Review
- 38 days
- Class
- Class II
- Product code
- HFW
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK994263 Securline Umbilical Cord Clamp Clipper #3540Precision Dynamics Corp. · 2000
- Descendant · cites it directly · 0 of its ownK041332 Joey Clamp Opening ToolMaternus, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK021055 Busse Umbilical Cord Clamp CutterBusse Hospital Disposables, Inc. · 2002
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) | K994263 | Securline Umbilical Cord Clamp Clipper #3540 | Precision Dynamics Corp. | 2000 | — |
| +1 | K041332 | Joey Clamp Opening Tool | Maternus, Inc. | 2004 | — |
| +1 | K021055 | Busse Umbilical Cord Clamp Cutter | Busse Hospital Disposables, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 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 HFW? 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?
The FDA summary names no predicate by number.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K041332 (Maternus, Inc., 2004) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HFW devicesHFW Clamp, Umbilical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HFW
FDA has decided no HFW device since 2007.
Median 510(k) review, days · HFW
Too few HFW 510(k)s in any year since 2007 to give a median.
Recalls per year · HFW
No recall names HFW since 2007.
Adverse event reports per year · HFW
2in 2024
MAUDE reports naming product code HFW, 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 | 3 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Securline® Umbilical Cord Clamp Clipper is used to cut the umbilical cord clamp off a newborn’s umbilical cord. The clipper jaws are placed over the “hinge” area of the umbilical cord clamp. Once appropriately located and engaged, pressure is applied to the clipper grips and the hinge is cut in half, removed, and disposed of properly.
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/K994263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994263: Securline Umbilical Cord Clamp Clipper #3540.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994263
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