510(k) Report

FDA applicant

Medical Device Consultants, Inc.

North Attleboro, MA14 decisions1982–200215 recalls

FDA records 14 decisions for Medical Device Consultants, Inc. (North Attleboro, MA) from 1982 to 2002: 14 510(k) clearances. Most are in product codes FTC (Light, Ultraviolet, Dermatological) and FTL (Mesh, Surgical, Polymeric). Its devices cite 3 predicates, 0 of them its own earlier devices. 15 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, general and plastic surgery panel, where it files most

How often FDA has decided Medical Device Consultants, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Device Consultants, Inc. since 2007.

Recalls per year

6in 2025

2019: 22024: 12025: 6
2007high 6 (2025) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Medical Device Consultants, 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?

  • FTCLight, Ultraviolet, Dermatological4decisions
  • FTLMesh, Surgical, Polymeric1decision
  • EHDUnit, X-Ray, Extraoral With Timer1decision
  • FMGStopcock, I.V. Set1decision
  • FFKLithotriptor, Electro-Hydraulic1decision
  • CGAGlucose Oxidase, Glucose1decision

Also: JBP (1), KDI (1), DTQ (1), INN (1), JPA (1).

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 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.

  • K002699Parietex Composite (Pco) MeshMedical Device Consultants, Inc. · 20018cite it
  • K022895Elcam Stopcocks and ManifoldsMedical Device Consultants, Inc. · 20025cite it
  • K000551Image X-70 Plus Dental X-Ray UnitMedical Device Consultants, Inc. · 20001cites it
  • K974164Swiss Lithoclast Master Handpiece and 3.2 MM ProbeMedical Device Consultants, Inc. · 19971cites it

What has FDA decided for it lately?

  • K022895Elcam Stopcocks and ManifoldsMedical Device Consultants, Inc. · 200214 recalls
  • K002699Parietex Composite (Pco) MeshMedical Device Consultants, Inc. · 2001
  • K002116S3 Cardioplegia Control Module Version 2.0Medical Device Consultants, Inc. · 2000
  • K000551Image X-70 Plus Dental X-Ray UnitMedical Device Consultants, Inc. · 2000
  • K974164Swiss Lithoclast Master Handpiece and 3.2 MM ProbeMedical Device Consultants, Inc. · 1997
  • K864282Glucose Testcard Use W/Ilex Prompt Clinical CH AnaMedical Device Consultants, Inc. · 1987
  • K860122Hemotec Act High Range Activated Clotting TimeMedical Device Consultants, Inc. · 19861 recall
  • K860931Ultrasun 3000 and 5000 Suntanning UnitMedical Device Consultants, Inc. · 1986

All 14 as Medical Device Consultants, Inc. →

What has been recalled?

15 recalls linked to its devices; the latest:

  • K022895IV Administration Set utilized in gravity IV administration sets and pump administration…Oct 29, 2025Class II
  • K032393IV Administration Set utilized in gravity IV administration sets and pump administration…Oct 29, 2025Class II
  • K032393IV Administration Set utilized in gravity IV administration sets and pump administration…Oct 29, 2025Class II
  • K022895IV Administration Set utilized in gravity IV administration sets and pump administration…Oct 29, 2025Class II
  • K022895IV Administration Set utilized in gravity IV administration sets and pump administration…Oct 29, 2025Class II
  • K860122Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03Oct 20, 2025Class II