510(k) · Cleared

Cleared

Umbilical Cord Clamp

K994367510(k) TraditionalCleared Mar 17, 200081-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

Medical Sales Co. · HFW Clamp, Umbilical

Cleared on Mar 17, 2000 as substantially equivalent to K990737 (Precision Dynamics Corp., 1999) after an 81-day review. Its family tree reaches back 2 generations to 1989.

Decided: Mar 17, 2000
Review: 81 days
Class: Class II
Product code: HFW
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K894646 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK894646 #556 Disposable Umbilical Cord Clamp (2)Alpha Unlimited, Inc. · 1989
1 generation backK990737 'Ecurline Umbilical Cord Clamp #3500Precision Dynamics Corp. · 1999
This deviceK994367 Umbilical Cord ClampMedical Sales Co. · 2000

View FIG. 1 as a table

Line of descent and top descendants

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

FIG. 1 — Lineage of K994367, 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.

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K990737	'Ecurline Umbilical Cord Clamp #3500 Summary page 1 …l 08. Product Code: 85 HFW Device Class: Class II 09. Performance Standards: No performance standards have been officially adopted by the FDA. 09. Predicate Device(s): K990737, et al, submissions, information attached, which were determined to be SE 510(k): UMBILICAL CLAMP Section 4 - 1 3063 South Davi…	Precision Dynamics Corp.	1999	—

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?

The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 9.6 years on median.
None of the 2 ancestors has a recall.

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?

Sterile, single-use, disposable umbilical cord clamp, 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, prior to and after cutting.

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/K994367 · printed Nov 6, 2026

Cite this page

510(k) Report. “K994367: Umbilical Cord Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994367

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