510(k) Report

510(k) · Cleared

Cleared

Joey Clamp Opening Tool

K041332510(k) TraditionalCleared Jun 25, 200437-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

Maternus, Inc. · HFW Clamp, Umbilical

Cleared on Jun 25, 2004 as substantially equivalent to K994263 (Precision Dynamics Corp., 2000) after a 37-day review. Its family tree reaches back 1 generation to 2000.

Decided
Jun 25, 2004
Review
37 days
Class
Class II
Product code
HFW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K994263 (2000). No later device cites it as a predicate yet.

K994263 · Securline Umbilical Cord Clamp Clipper #3540 · Precision Dynamics Corp. · 20002000200220042006
K994263 · Securline Umbilical Cord Clamp Clipper #3540 · Precision Dynamics Corp. · 20000
  1. Root · 1 generation backK994263 Securline Umbilical Cord Clamp Clipper #3540Precision Dynamics Corp. · 2000
  2. This deviceK041332 Joey Clamp Opening ToolMaternus, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K994263Securline Umbilical Cord Clamp Clipper #3540Precision Dynamics Corp.2000—
0 (this device)K041332Joey Clamp Opening ToolMaternus, Inc.2004—
FIG. 1 — Lineage of K041332, 2000–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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.

TypeNumberDeviceApplicantDecidedRecalls
*K994263Securline Umbilical Cord Clamp Clipper #3540
Summary page 1
…g Tool is substantially equivalent to the Secureline® Umbilical Cord Clamp Clipper [510 (k) No. K994263] that is legally marketed in the U.S.. V. Statement of Intended Use: The indication…
Precision Dynamics Corp.2000—

Also cleared against K994263: 1 other device →

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?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K994263.

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—

What is it indicated for?

The indications for use of the Joey Clamp Opening Tool is to open the Joey Clamp® umbilical cord clamp.

Indications for use as stated in the FDA summary.

Also cleared against K994263

1 other device cites the same predicate.

  • K021055Busse Umbilical Cord Clamp CutterBusse Hospital Disposables, Inc. · 2002

More from Maternus, Inc.

3 FDA decisions under this applicant name. See the company

  • K011621Koala Clamp, Koala Clamp and CutterMaternus, Inc. · 2001
  • K010695Koala ClampMaternus, Inc. · 2001

Recent decisions in HFW

The HFW category page

  • 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
  • K011621Koala Clamp, Koala Clamp and CutterMaternus, Inc. · 2001

https://510kreport.com/device/K041332 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041332: Joey Clamp Opening Tool.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041332

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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