510(k) Report

FDA applicant

Std Mfg., Inc.

Stoughton, MA6 decisions1993–20035 recalls

FDA records 6 decisions for Std Mfg., Inc. (Stoughton, MA) from 1993 to 2003: 6 510(k) clearances. Most are in product codes GDW (Staple, Implantable) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 6 predicates, 1 of them its own earlier devices. 5 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 Std Mfg., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Std Mfg., Inc. since 2007.

Recalls per year

5in 2014

2014: 5
2007high 5 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Std Mfg., 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?

  • GDWStaple, Implantable3decisions
  • GCJLaparoscope, General & Plastic Surgery1decision
  • KXAProsthesis, Hip, Femoral, Resurfacing1decision
  • HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1decision

Whose devices does it build on?

Its devices cite 6 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.

  • K023096Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing SystemStd Mfg., Inc. · 20033cite it
  • K003169Vascular Closure DeviceStd Mfg., Inc. · 20001cites it

What has FDA decided for it lately?

  • K023096Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing SystemStd Mfg., Inc. · 20035 recalls
  • K021549Contoured Articular Prosthesis (Cap) Femoral Head Resurfacing SystemStd Mfg., Inc. · 2002
  • K012362Modification to Vascular Closure DeviceStd Mfg., Inc. · 2001
  • K003169Vascular Closure DeviceStd Mfg., Inc. · 2000
  • K000608Suction Vascular Stapler and Implantable Staple SystemStd Mfg., Inc. · 2000
  • K930427STD Irrigation PumpStd Mfg., Inc. · 1993

All 6 as Std Mfg., Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K023096Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032…Nov 24, 2014Class II
  • K023096Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number…Nov 24, 2014Class II
  • K023096Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875…Nov 24, 2014Class II
  • K023096Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number…Nov 24, 2014Class II
  • K023096Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number…Nov 24, 2014Class II