510(k) Report

510(k) · Cleared

Cleared

Umbilical Clamp and Cutter

K963428510(k) TraditionalCleared Apr 1, 1997214-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

R.O.S.T. Medical Development, Inc. · HFW Clamp, Umbilical

Cleared on Apr 1, 1997 after a 214-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Apr 1, 1997
Review
214 days
Class
Class II
Product code
HFW
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2001: 1 descendant cleared2016: 1 descendant cleared1995200020052010201520202025
  1. This deviceK963428 Umbilical Clamp and CutterR.O.S.T. Medical Development, Inc. · 1997
  2. Descendant · cites it directly · 2 of its ownK982464 SCC-23 Safety Clamp and CutterWomen First Healthcare, Inc. · 1998
  3. Descendant · 2 generations on · 1 of its ownK011621 Koala Clamp, Koala Clamp and CutterMaternus, Inc. · 2001
  4. Descendant · 3 generations on · 0 of its ownK152350 Regular and Special Umbilical Cord Clamp and CutterNingbo Feite Medical Device Co., Ltd. · 2016

Most influential descendants

Showing 3 of 3 · See all
  • K982464SCC-23 Safety Clamp and CutterWomen First Healthcare, Inc. · 1998 · cites it directly2descendants
  • K011621Koala Clamp, Koala Clamp and CutterMaternus, Inc. · 2001 · 2 generations on1descendant
  • K152350Regular and Special Umbilical Cord Clamp and CutterNingbo Feite Medical Device Co., Ltd. · 2016 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K963428Umbilical Clamp and CutterR.O.S.T. Medical Development, Inc.1997—
+1K982464SCC-23 Safety Clamp and CutterWomen First Healthcare, Inc.1998—
+2K011621Koala Clamp, Koala Clamp and CutterMaternus, Inc.2001—
+3K152350Regular and Special Umbilical Cord Clamp and CutterNingbo Feite Medical Device Co., Ltd.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200110
201610
FIG. 1 — Lineage of K963428, 1997–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K982464SCC-23 Safety Clamp and CutterWomen First Healthcare, Inc.19982

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, K982464 (Women First Healthcare, Inc., 1998) has gone furthest, with 2 descendants of its own.

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

2008: 32009: 32011: 32013: 42014: 12015: 12016: 12017: 22018: 72020: 12021: 12024: 2
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—03
20090—03
20100—00
20110—03
20120—00
20130—04
20140—01
20150—01
20160—01
20170—02
20180—07
20190—00
20200—01
20210—01
20220—00
20230—00
20240—02
20250—00
20260—0—

Recent decisions in HFW

The HFW category page

  • K041332Joey Clamp Opening ToolMaternus, Inc. · 2004
  • K033846Kaen Yih Umbilical Cord ClampKaen Yih Enterprise Co., Ltd. · 2004
  • K020718Securline Umbilical Cord Clamp #3505 Sterile #3515 Non-SterilePrecision Dynamics Corp. · 2002
  • K021055Busse Umbilical Cord Clamp CutterBusse Hospital Disposables, Inc. · 2002
  • K012917Dynarex Umbilical Cord Lamp, Models 6833 and 6833-BDynarex Corp. · 2001

https://510kreport.com/device/K963428 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963428: Umbilical 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/K963428

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026