510(k) Report

510(k) · Cleared

Cleared

Compression Forceps

K890382510(k) TraditionalCleared Feb 27, 198935-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

Kinetic Medical Products · HFW Clamp, Umbilical

Cleared on Feb 27, 1989 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 27, 1989
Review
35 days
Class
Class II
Product code
HFW
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K890382Source: 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.

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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 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—
Cite this page

510(k) Report. “K890382: Compression Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K890382

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