510(k) Report

510(k) · Cleared

Cleared

Intestinal Crushing Clamp

K890371510(k) TraditionalCleared Feb 3, 198911-day reviewClass I21 CFR 878.4800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kinetic Medical Products · HXD Clamp

Cleared on Feb 3, 1989 after an 11-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 3, 1989
Review
11 days
Class
Class I
Product code
HXD
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K890371Source: FDA 510(k) database · 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 HXD? 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?

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.

How does its category compare?

All HXD devices

HXD Clamp: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HXD

FDA has decided no HXD device since 2007.

Median 510(k) review, days · HXD

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

Recalls per year · HXD

No recall names HXD since 2007.

Adverse event reports per year · HXD

123in 2025

2007: 62008: 42009: 262010: 22011: 42013: 62014: 42015: 62016: 762017: 1312018: 1122019: 1252020: 1142021: 752022: 882023: 992024: 1352025: 123
2007high 135 (2024) · low 0 (2012)2025

MAUDE reports naming product code HXD, 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—06
20080—04
20090—026
20100—02
20110—04
20120—00
20130—06
20140—04
20150—06
20160—076
20170—0131
20180—0112
20190—0125
20200—0114
20210—075
20220—088
20230—099
20240—0135
20250—0123
20260—0—

More from Kinetic Medical Products

63 FDA decisions under this applicant name. See the company

  • K890385Midwifery/Obstetrical ForcepsKinetic Medical Products · 1989
  • K890387Malleable Placenta CuretteKinetic Medical Products · 1989
  • K890376Vaginal SpeculumKinetic Medical Products · 1989
  • K890382Compression ForcepsKinetic Medical Products · 1989
  • K890380Cervical Biopsy ForcepsKinetic Medical Products · 1989

Recent decisions in HXD

The HXD category page

  • K890372Intestinal ClampKinetic Medical Products · 1989
  • K890381Parametrium ClampKinetic Medical Products · 1989
  • K890368Kidney ClampKinetic Medical Products · 1989
  • K874959Vascular ClampSolway, Inc. · 1987
  • K872386C ClampMed-Tool, Inc. · 1987

https://510kreport.com/device/K890371 · printed Nov 5, 2026

Cite this page

510(k) Report. “K890371: Intestinal Crushing Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K890371

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