FDA applicant

Sims Level 1, Inc.

Rockland, MA2 decisions2000–20011 recall

FDA records 2 decisions for Sims Level 1, Inc. (Rockland, MA) from 2000 to 2001: 2 510(k) clearances. Most are in product codes LGZ (Warmer, Thermal, Infusion Fluid) and DWJ (System, Thermal Regulating). Its devices cite 1 predicate, 0 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 Sims Level 1, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sims Level 1, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sims Level 1, 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

Other applicant names beginning “Sims”

FDA records each applicant name separately; these may or may not be the same firm.

Sims Deltec, Inc. 32 Sims Portex, Inc. 16 Sims Surgical, Inc. 3 Sims 2

Sims Level 1, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Sims”