510(k) Report

FDA applicant

Gpc Medical Limited

New Delhi, IN6 decisions2010–20220 recalls

FDA records 6 decisions for Gpc Medical Limited (New Delhi, IN) from 2010 to 2022: 6 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HSB (Rod, Fixation, Intramedullary And Accessories). Since 2016 its 510(k)s took a median of 247 days from receipt to decision, against 127 for FDA’s reviews in the same codes and years. Its devices cite 36 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Gpc Medical, Ltd.”.

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

FIG. A — Illustration, orthopedic panel, where it files most

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

FDA decisions per year

2in 2022

2010: 12015: 12016: 12017: 12022: 2
2010high 2 (2022) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Gpc Medical Limited by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gpc Medical Limited’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?

  • HRSPlate, Fixation, Bone3decisions
  • HSBRod, Fixation, Intramedullary And Accessories2decisions
  • NKBThoracolumbosacral Pedicle Screw System1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 247 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 127 days; 0 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 36 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 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.

  • K092493GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate SystemGpc Medical, Ltd. · 20104cite it
  • K143245GPC Intramedullary Nailing SystemsGpc Medical Limited · 20152cite it
  • K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd. · 20161cites it

What has FDA decided for it lately?

  • K203811GPC Intraheal Intramedullary Nailing SystemGpc Medical Limited · 2022
  • K210198GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable…Gpc Medical Limited · 2022
  • K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited · 2017
  • K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd. · 2016
  • K143245GPC Intramedullary Nailing SystemsGpc Medical Limited · 2015
  • K092493GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate SystemGpc Medical, Ltd. · 2010

All 4 as Gpc Medical Limited →All 2 as Gpc Medical, Ltd. →