510(k) Report

510(k) · Cleared

Cleared

Regular and Special Umbilical Cord Clamp and Cutter

K152350510(k) TraditionalCleared Jun 28, 2016313-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

Ningbo Feite Medical Device Co., Ltd. · NBZ Clamp And Cutter, Umbilical

Cleared on Jun 28, 2016 as substantially equivalent to K011621 (Maternus, Inc., 2001) after a 313-day review. Its family tree reaches back 3 generations to 1997.

Decided
Jun 28, 2016
Review
313 days
Class
Class II
Product code
NBZ
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K963428 (1997). No later device cites it as a predicate yet.

K963428 · Umbilical Clamp and Cutter · R.O.S.T. Medical Development, Inc. · 1997K982464 · SCC-23 Safety Clamp and Cutter · Women First Healthcare, Inc. · 1998K011621 · Koala Clamp, Koala Clamp and Cutter · Maternus, Inc. · 200119952000200520102015
K011621 · Koala Clamp, Koala Clamp and Cutter · Maternus, Inc. · 2001K982464 · SCC-23 Safety Clamp and Cutter · Women First Healthcare, Inc. · 1998K963428 · Umbilical Clamp and Cutter · R.O.S.T. Medical Development, Inc. · 19970
  1. Root · 3 generations backK963428 Umbilical Clamp and CutterR.O.S.T. Medical Development, Inc. · 1997
  2. 2 generations backK982464 SCC-23 Safety Clamp and CutterWomen First Healthcare, Inc. · 1998
  3. 1 generation backK011621 Koala Clamp, Koala Clamp and CutterMaternus, Inc. · 2001
  4. This deviceK152350 Regular and Special Umbilical Cord Clamp and CutterNingbo Feite Medical Device Co., Ltd. · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K963428Umbilical Clamp and CutterR.O.S.T. Medical Development, Inc.1997—
−2K982464SCC-23 Safety Clamp and CutterWomen First Healthcare, Inc.1998—
−1K011621Koala Clamp, Koala Clamp and CutterMaternus, Inc.2001—
0 (this device)K152350Regular and Special Umbilical Cord Clamp and CutterNingbo Feite Medical Device Co., Ltd.2016—
FIG. 1 — Lineage of K152350, 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), 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 NBZ? 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? (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
*K011621Koala Clamp, Koala Clamp and Cutter
Summary page 4
…lation Number: 21 CFR 884.4530 Panel: General Obstetrics/Gynecology Product Code: NBZ 5.5 Predicate Device Information: (1) K011621, “Koala Clamp and Cutter”, manufactured by “Maternus Inc.” in San Antonio, TX. 5.6 Device Description: “Regular and S…
Maternus, Inc.2001—

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 19 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
  • None of the 3 ancestors has a recall.

How does its category compare?

All NBZ devices

NBZ Clamp And Cutter, Umbilical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · NBZ

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NBZ

Too few NBZ 510(k)s in any year since 2007 to give a median.

Recalls per year · NBZ

No recall names NBZ since 2007.

Adverse event reports per year · NBZ

2in 2023

2023: 2
2007high 2 (2023) · low 0 (2007)2025

MAUDE reports naming product code NBZ, 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—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20161—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—02
20240—00
20250—00
20260—0—

What is it indicated for?

Regular and Special Umbilical Cord Clamp and Cutter are intended for use in simultaneously clamping and cutting the

umbilical cord of the new born baby at delivery

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K152350 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152350: Regular and Special Umbilical Cord 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/K152350

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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