510(k) Report

510(k) · Cleared

Cleared

Surgical Towel Clips

K890231510(k) TraditionalCleared Jan 27, 19899-day reviewClass I21 CFR 882.4215

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

Kinetic Medical Products · HBR Rack, Clip

Cleared on Jan 27, 1989 after a 9-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 27, 1989
Review
9 days
Class
Class I
Product code
HBR
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K890231Source: 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 HBR devices

HBR Rack, Clip: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HBR

FDA has decided no HBR device since 2007.

Median 510(k) review, days · HBR

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

Recalls per year · HBR

No recall names HBR since 2007.

Adverse event reports per year · HBR

No MAUDE report names HBR since 2007.

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
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
Cite this page

510(k) Report. “K890231: Surgical Towel Clips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K890231

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