510(k) Report

510(k) · Cleared

Cleared

Sterile Polyhesive PBS Dressing

K890021510(k) TraditionalCleared Jun 1, 1989148-day reviewClass III

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

Valleylab, Inc. · KGF Adhesive, Tissue For Aneurysmorrhaphy

Cleared on Jun 1, 1989 after a 148-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 1, 1989
Review
148 days
Class
Class III
Product code
KGF
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K890021Source: 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 KGF? 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 KGF devices

KGF Adhesive, Tissue For Aneurysmorrhaphy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGF

FDA has decided no KGF device since 2007.

Median 510(k) review, days · KGF

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

Recalls per year · KGF

No recall names KGF since 2007.

Adverse event reports per year · KGF

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2025

MAUDE reports naming product code KGF, 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—01
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—

More from Valleylab, Inc.

94 FDA decisions under this applicant name. See the company

  • K031011Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 20032 recalls
  • K010010Valleylab Ligasure Precise Instrument Vessel Sealing System-Model # LS1200 & Sligaure GeneratorValleylab, Inc. · 2001
  • K010013Ligasure Laparoscopic Sealer Divider Model LS1100Valleylab, Inc. · 20012 recalls
  • K994428E7512 Premie Rem Polyhesive II Patient Return ElectrodeValleylab, Inc. · 2000
  • K983743Bisure Laparoscopic Bipolar ForcepsValleylab, Inc. · 1999

https://510kreport.com/device/K890021 · printed Nov 6, 2026

Cite this page

510(k) Report. “K890021: Sterile Polyhesive PBS Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K890021

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