510(k) · Cleared
ClearedSecurline Umbilical Cord Clamp #3505 Sterile #3515 Non-Sterile
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 Jun 3, 2002 as substantially equivalent to K880753 (I M, Inc., 1988) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1978.
- Decided
- Jun 3, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- HFW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K781548 (1978). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK781548 Umbilical Cord ClampHollister, Inc. · 1978
- This deviceK020718 Securline Umbilical Cord Clamp #3505 Sterile #3515 Non-SterilePrecision Dynamics Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K781548 | Umbilical Cord Clamp | Hollister, Inc. | 1978 | — |
| 0 (this device) | K020718 | Securline Umbilical Cord Clamp #3505 Sterile #3515 Non-Sterile | Precision Dynamics Corp. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 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? (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 |
|---|---|---|---|
| * | K880753 | Umbilical Cord ClampSummary page 1…the following devices as a predicate: 1 IM Inc. Umbilical Cord Clamp 51O(k) 880753 1 HolIistertO Double Grip@Umbilica… | 1988 |
| * | K781548 | Umbilical Cord ClampSummary page 1…1 HolIistertO Double Grip@Umbilical Cord Clamp 510(k) 781548 1 Alpha Unlimited, Inc. Disposable Umbilical Cord Clamp… | 1978 |
| * | K894646 | #556 Disposable Umbilical Cord Clamp (2)Summary page 1…781548 1 Alpha Unlimited, Inc. Disposable Umbilical Cord Clamp 51O( k) 894646 Description of the device: The Securline@Umbilical Cord Clamp is a single use, disposable, molded… | 1989 |
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?
- None of the 3 ancestors has a recall.
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 is used to clamp over the umbilical cord of a newborn at delivery. The device is used to hold the cord securely and prevent blood loss and seepage as the cord dries and shrinks after the birth.
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/K020718 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020718: Securline Umbilical Cord Clamp #3505 Sterile #3515 Non-Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020718
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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