510(k) Report

FDA applicant

Martech Medical Products, Inc.

Harleysville, PA11 decisions1989–20260 recalls

FDA records 11 decisions for Martech Medical Products, Inc. (Harleysville, PA) from 1989 to 2026: 11 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and JKA (Tubes, Vials, Systems, Serum Separators, Blood…). Its devices cite 9 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Martech Medical Products”.

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 Martech Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2010: 12012: 12013: 12026 (partial year): 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • DYBIntroducer, Catheter3decisions
  • JKATubes, Vials, Systems, Serum Separators, Blood Collection2decisions
  • CCLAnalyzer, Gas, Oxygen, Gaseous-Phase1decision
  • FBKEndoscopic Injection Needle, Gastroenterology-Urology1decision
  • FMFSyringe, Piston1decision
  • FMINeedle, Hypodermic, Single Lumen1decision

Also: CBT (1), PTI (1).

Whose devices does it build on?

Its devices cite 9 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K960519Martech Endoscopic Injection NeedleMartech Medical Products, Inc. · 19962cite it
  • K120617Ptfe Super Sheath IntroducerMartech Medical Products · 20121cites it
  • K130855Ptfe Super Sheath IntroducerMartech Medical Products · 20131cites it

What has FDA decided for it lately?

  • K25409525G Huber NeedleMartech Medical Products · 2026
  • K130855Ptfe Super Sheath IntroducerMartech Medical Products · 2013
  • K120617Ptfe Super Sheath IntroducerMartech Medical Products · 2012
  • K101399Coaxial Introducer SetMartech Medical Products · 2010
  • K960519Martech Endoscopic Injection NeedleMartech Medical Products, Inc. · 1996
  • K931924Marksman Arterial Blood Gas SyringeMartech Medical Products, Inc. · 1993
  • K922438PRO2 Oxygen AnalyzerMartech Medical Products, Inc. · 1993
  • K926007Accessory to Piston SyringeMartech Medical Products, Inc. · 1993

All 7 as Martech Medical Products, Inc. →All 4 as Martech Medical Products →