510(k) · Cleared

Cleared

'Ecurline Umbilical Cord Clamp #3500

K990737510(k) TraditionalCleared Apr 6, 199932-day reviewClass II21 CFR 884.4530

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Precision Dynamics Corp. · HFW Clamp, Umbilical

Cleared on Apr 6, 1999 as substantially equivalent to K894646 (Alpha Unlimited, Inc., 1989) after a 32-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.

Decided: Apr 6, 1999
Review: 32 days
Class: Class II
Product code: HFW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K894646 (1989). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK894646 #556 Disposable Umbilical Cord Clamp (2)Alpha Unlimited, Inc. · 1989
This deviceK990737 'Ecurline Umbilical Cord Clamp #3500Precision Dynamics Corp. · 1999
Descendant · cites it directly · 0 of its ownK994367 Umbilical Cord ClampMedical Sales Co. · 2000

Most influential descendants

Showing 1 of 1 · See all

K994367Umbilical Cord ClampMedical Sales Co. · 2000 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K894646	#556 Disposable Umbilical Cord Clamp (2)	Alpha Unlimited, Inc.	1989	—
0 (this device)	K990737	'Ecurline Umbilical Cord Clamp #3500	Precision Dynamics Corp.	1999	—
+1	K994367	Umbilical Cord Clamp	Medical Sales Co.	2000	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

FIG. 1 — Lineage of K990737, 1989–2000Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

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Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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	Applicant	Decided	Recalls
*	K894646	#556 Disposable Umbilical Cord Clamp (2) Summary page 1 …1409-9043, USA /( 9 3 7 P ® 510k Summary Precision Dynamics Corporation purchases the umbilical cord clamp (non-sterile) from Alpha Unlimited, Inc (refer to the 510k K894646) and then contracts the packaging and sterilization through ARMM, Inc. ARMM, Inc. packages the umbilical cord clamp in a plastic/…	Alpha Unlimited, Inc.	1989	—

Also cleared against K894646: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K994367	Umbilical Cord Clamp	Medical Sales Co.	2000	0

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, K994367 (Medical Sales Co., 2000) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K894646.

How does its category compare?

All HFW devices

HFW 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

2007high 7 (2018) · low 0 (2007)2025

MAUDE reports naming product code HFW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	3
2009	—	3
2010	—	0
2011	—	3
2012	—	0
2013	—	4
2014	—	1
2015	—	1
2016	—	1
2017	—	2
2018	—	7
2019	—	0
2020	—	1
2021	—	1
2022	—	0
2023	—	0
2024	—	2
2025	—	0
2026	—	—

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 blodd 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/K990737 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990737: 'Ecurline Umbilical Cord Clamp #3500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990737

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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