510(k) Report

FDA applicant

Einstein Works, LLC

Houston, TX3 decisions2019–20210 recalls

FDA records 3 decisions for Einstein Works, LLC (Houston, TX) from 2019 to 2021: 3 510(k) clearances. All are in product code FMI (Needle, Hypodermic, Single Lumen). Since 2016 its 510(k)s took a median of 166 days from receipt to decision, against 186 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 of them its own earlier devices. No 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 Einstein Works, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2019: 22021: 1
2019high 2 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Einstein Works, LLC by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Einstein Works, LLC’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 Lumen3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 166 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 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K182770Adult Intraosseous Infusion DeviceEinstein Works, LLC · 20191cites it

What has FDA decided for it lately?

  • K211395NIO-IEinstein Works, LLC · 2021
  • K191258Intraosseous infusion deviceEinstein Works, LLC · 2019
  • K182770Adult Intraosseous Infusion DeviceEinstein Works, LLC · 2019

All 3 as Einstein Works, LLC →