510(k) Report

FDA applicant

Blairden Precision Instruments, Inc.

Lenexa, KS2 decisions1991–19942 recalls

FDA records 2 decisions for Blairden Precision Instruments, Inc. (Lenexa, KS) from 1991 to 1994: 2 510(k) clearances. Most are in product codes LKF (Cannula, Manipulator/Injector, Uterine) and GFA (Blade, Saw, General & Plastic Surgery, Surgical). 2 recalls are linked to its devices.

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

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Blairden Precision Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Blairden Precision Instruments, Inc. since 2007.

Recalls per year

2in 2012

2012: 2
2007high 2 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Blairden Precision Instruments, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LKFCannula, Manipulator/Injector, Uterine1decision
  • GFABlade, Saw, General & Plastic Surgery, Surgical1decision

What has FDA decided for it lately?

  • K932115Rowden Uterine Manipulator Injector and RumiBlairden Precision Instruments, Inc. · 19942 recalls
  • K912761Surgical Saw BladesBlairden Precision Instruments, Inc. · 1991

All 2 as Blairden Precision Instruments, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K932115Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended…Oct 31, 2012Class II
  • K932115Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The…Oct 31, 2012Class II