510(k) Report

FDA applicant

Kmi Kolster Methods, Inc.

Anaheim, CA6 decisions1999–20061 recall

FDA records 6 decisions for Kmi Kolster Methods, Inc. (Anaheim, CA) from 1999 to 2006: 6 510(k) clearances. Most are in product codes GAW (Suture, Nonabsorbable, Synthetic, Polypropylene) and LHC (Warmer, Irrigation Solution). 1 recall is linked to its devices.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Kmi Kolster Methods, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kmi Kolster Methods, Inc. since 2007.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Kmi Kolster Methods, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GAWSuture, Nonabsorbable, Synthetic, Polypropylene2decisions
  • LHCWarmer, Irrigation Solution1decision
  • IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat1decision
  • QPBSystem, Suction, Lipoplasty For Removal1decision
  • FRNPump, Infusion1decision

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K060414Kolster Methods, Inc., Featherlift Silhouette SutureKmi Kolster Methods, Inc. · 20062cite it
  • K991203Irrigation or Infusion Pump K PumpKmi Kolster Methods, Inc. · 19992cite it
  • K012236STARS2000 Power CannulaKmi Kolster Methods, Inc. · 20011cites it

What has FDA decided for it lately?

  • K060414Kolster Methods, Inc., Featherlift Silhouette SutureKmi Kolster Methods, Inc. · 20061 recall
  • K043591Featherlift Extended Aptos ThreadKmi Kolster Methods, Inc. · 2005
  • K012236STARS2000 Power CannulaKmi Kolster Methods, Inc. · 2001
  • K010702Xub External UltrasoundKmi Kolster Methods, Inc. · 2001
  • K002859SSW-Sterile Solution WarmerKmi Kolster Methods, Inc. · 2000
  • K991203Irrigation or Infusion Pump K PumpKmi Kolster Methods, Inc. · 1999

All 6 as Kmi Kolster Methods, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K060414Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to…Jul 2, 2015Class II