510(k) Report

FDA applicant

Waismed, Ltd.

Rosh Ha'Ayin, IL7 decisions1998–20213 recalls

FDA records 7 decisions for Waismed, Ltd. (Rosh Ha'Ayin, IL) from 1998 to 2021: 7 510(k) clearances. All are in product code FMI (Needle, Hypodermic, Single Lumen). Since 2016 its 510(k)s took a median of 92 days from receipt to decision, against 186 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 6 of them its own earlier devices. 3 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 hospital panel, where it files most

How often FDA has decided Waismed, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2014: 12016: 12019: 12021: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2025

2016: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Waismed, Ltd.’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?

  • FMINeedle, Hypodermic, Single Lumen7decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 92 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 186 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 6 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.

  • K981853Bone Injection Gun (B.I.G.) DeviceWaismed, Ltd. · 19985cite it
  • K142086Nio -Intraosseous DeviceWaismed, Ltd. · 20142cite it
  • K062940Bone Injection Gun (B.I.G.)Waismed, Ltd. · 20062cite it
  • K160805NIO-PWaismed, Ltd. · 20161cites it
  • K022415Bone Injection Gun (B.I.G.) for Pediatrics, Model 1STWaismed, Ltd. · 20021cites it
  • K190538NIO-IWaismed, Ltd. · 20191cites it

What has FDA decided for it lately?

  • K211968NIO+ AdultWaismed, Ltd. · 20211 recall
  • K190538NIO-IWaismed, Ltd. · 2019
  • K160805NIO-PWaismed, Ltd. · 20161 recall
  • K142086Nio -Intraosseous DeviceWaismed, Ltd. · 20141 recall
  • K062940Bone Injection Gun (B.I.G.)Waismed, Ltd. · 2006
  • K022415Bone Injection Gun (B.I.G.) for Pediatrics, Model 1STWaismed, Ltd. · 2002
  • K981853Bone Injection Gun (B.I.G.) DeviceWaismed, Ltd. · 1998

All 7 as Waismed, Ltd. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K211968Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number…Jun 5, 2025Class II
  • K142086Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number…Jun 5, 2025Class II
  • K160805NIO-A / NIO-P is an instant IO access device comprises housing with spring load…Aug 18, 2016Class II