510(k) Report

FDA applicant

Great Batch Medical

Plymouth, MN11 decisions2009–20187 recalls

FDA records 11 decisions for Great Batch Medical (Plymouth, MN) from 2009 to 2018: 10 510(k) clearances and 1 original PMA approval. Most are in product codes DYB (Introducer, Catheter) and DRC (Trocar). Its devices cite 12 predicates, 1 of them its own earlier devices. 7 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, cardiovascular panel, where it files most

How often FDA has decided Great Batch Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2009: 12010: 32011: 12012: 32013: 12015: 12018: 1
2009high 3 (2010) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2017

2010: 12012: 32013: 12016: 12017: 1
2009high 3 (2012) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Great Batch Medical by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Great Batch Medical’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?

  • DYBIntroducer, Catheter7decisions
  • DRCTrocar2decisions
  • DTBPermanent Pacemaker Electrode1decision
  • DRACatheter, Steerable1decision

Whose devices does it build on?

Its devices cite 12 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K093023Ptfe Peelable IntroducerGreat Batch Medical · 20091cites it
  • K102540Ptfe Portable IntroducerGreat Batch Medical · 20101cites it
  • K110051Radialsource Transradial Access Introducer KitGreat Batch Medical · 20121cites it

What has FDA decided for it lately?

  • K181855RadialSeal Introducer KitGreat Batch Medical · 2018
  • P130012Myopore Sutureless Myocardial Pacing LeadGreat Batch Medical · 2015
  • K130559Mobicath BI-Directional Guiding SheathGreat Batch Medical · 20131 recall
  • K122832Mobicath Transseptal NeedleGreat Batch Medical · 2012
  • K112541Z Flex-270TM Steerable SheathGreat Batch Medical · 20121 recall
  • K110051Radialsource Transradial Access Introducer KitGreat Batch Medical · 20121 recall
  • K111644Mobicath Transseptal NeedleGreat Batch Medical · 2011
  • K101784Mobicath BI-Directional Guiding Sheath Model 1000182-XXXGreat Batch Medical · 20103 recalls

All 11 as Great Batch Medical →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K130559Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and…Feb 15, 2017Class II
  • K101784CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in…Sep 19, 2016Class II
  • K110051Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit.…May 31, 2013Class II
  • K101784Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no.…Nov 12, 2012Class II
  • K101784Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no.…Sep 24, 2012Class II
  • K112541Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by…Sep 6, 2012Class II

Other applicant names beginning “Great”

FDA records each applicant name separately; these may or may not be the same firm.

Great Lakes Orthodontics, Ltd. 13Great Glove Sdn Bhd 4Great Basin Scientific, Inc. 4Great Glove (China), Inc. 2Great Eastern Lumber Co., Inc. 2Great Glove (Thailand) Co., Ltd. 2Great Field Industries Co., Ltd. 1Great Eco Glove Sdn. Bhd. 1Great Future Works, Ltd. 1Great Lakes Intl. 1Great West Medical Equipment, Inc. 1Great Bay Medical Products, Inc. 1