510(k) Report

510(k) · Cleared

Cleared

Posi-Grip Umbilical Cord Clamp, Sterile, Model 384, Posi-Grip Umbilical Cord Clamp, Non-Sterile, Model 385

K010835510(k) TraditionalCleared Apr 30, 200141-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

Busse Hospital Disposables, Inc. · HFW Clamp, Umbilical

Cleared on Apr 30, 2001 after a 41-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Apr 30, 2001
Review
41 days
Class
Class II
Product code
HFW
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared200020052010201520202025
  1. This deviceK010835 Posi-Grip Umbilical Cord Clamp, Sterile, Model 384, Posi-Grip…Busse Hospital Disposables, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK021055 Busse Umbilical Cord Clamp CutterBusse Hospital Disposables, Inc. · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K021055Busse Umbilical Cord Clamp CutterBusse Hospital Disposables, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010835Posi-Grip Umbilical Cord Clamp, Sterile, Model 384, Posi-Grip Umbilical Cord…Busse Hospital Disposables, Inc.2001—
+1K021055Busse Umbilical Cord Clamp CutterBusse Hospital Disposables, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K010835, 2001–2002Source: 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K021055Busse Umbilical Cord Clamp CutterBusse Hospital Disposables, Inc.20020

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, K021055 (Busse Hospital Disposables, Inc., 2002) has gone furthest, with 0 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—

More from Busse Hospital Disposables, Inc.

31 FDA decisions under this applicant name. See the company

  • K120002I-Style Bone Marrow Aspiration Needle with T-HandleBusse Hospital Disposables, Inc. · 2012
  • K093909Busse Surgical Drapes IVBusse Hospital Disposables, Inc. · 2010
  • K092212Busse Surgical Drapes IiiBusse Hospital Disposables, Inc. · 2009
  • K082297Busse Surgical DrapeBusse Hospital Disposables, Inc. · 2008
  • K073222Modification to:Specialty NeedlesBusse Hospital Disposables, Inc. · 2008

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/K010835 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010835: Posi-Grip Umbilical Cord Clamp, Sterile, Model 384, Posi-Grip Umbilical Cord Clamp, Non-Sterile, Model 385.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010835

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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