510(k) Report

FDA applicant

Pyng Medical Corp.

Richmond, B.C., CA5 decisions1997–20131 recall

FDA records 5 decisions for Pyng Medical Corp. (Richmond, B.C., CA) from 1997 to 2013: 5 510(k) clearances. All are in product code FMI (Needle, Hypodermic, Single Lumen). Its devices cite 9 predicates, 5 of them its own earlier devices. 1 recall is 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 hospital panel, where it files most

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

FDA decisions per year

1in 2013

2008: 22010: 12013: 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Pyng Medical Corp.’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?

  • FMINeedle, Hypodermic, Single Lumen5decisions

Whose devices does it build on?

Its devices cite 9 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 5 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.

  • K970380F.a.S.T. 1 Intraosseous Infusion SystemPyng Medical Corp. · 19973cite it
  • K080865FAST1 Intraosseous Infusion SystemPyng Medical Corp. · 20083cite it
  • K130487Fastresponder Sternal Intraosseous DevicePyng Medical Corp. · 20131cites it
  • K072487FAST1 Intraosseous Infusion SystemPyng Medical Corp. · 20081cites it
  • K100124Fastx Sternal Intraosseous DevicePyng Medical Corp. · 20101cites it

What has FDA decided for it lately?

  • K130487Fastresponder Sternal Intraosseous DevicePyng Medical Corp. · 2013
  • K100124Fastx Sternal Intraosseous DevicePyng Medical Corp. · 20101 recall
  • K080865FAST1 Intraosseous Infusion SystemPyng Medical Corp. · 2008
  • K072487FAST1 Intraosseous Infusion SystemPyng Medical Corp. · 2008
  • K970380F.a.S.T. 1 Intraosseous Infusion SystemPyng Medical Corp. · 1997

All 5 as Pyng Medical Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K100124The product is the "FASTx Sternal Intraosseous Device". The expiration date for the…Nov 5, 2010