510(k) Report

FDA applicant

Enginivity, LLC

Kittery, ME1 decision2006–20066 recalls

FDA records 1 decision for Enginivity, LLC (Kittery, ME) in 2006: 1 510(k) clearance. All are in product code LGZ (Warmer, Thermal, Infusion Fluid). Its devices cite 1 predicate, 0 of them its own earlier devices. 6 recalls are linked to its devices, 2 Class I.

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 Enginivity, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Enginivity, LLC since 2007.

Recalls per year

2in 2019

2009: 12010: 12011: 12012: 12019: 2, 2 Class I
2007high 2 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Enginivity, 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?

  • LGZWarmer, Thermal, Infusion Fluid1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K060537Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow AC Power Supply, Model 120Enginivity, LLC · 20062cite it

What has FDA decided for it lately?

  • K060537Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow AC Power Supply, Model 120Enginivity, LLC · 20062 Class I recalls

The one decision as Enginivity, LLC →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K130867enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood…Mar 13, 2019Class I
  • K130867enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy…Mar 13, 2019Class I
  • K060537enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE…Feb 20, 2012Class II
  • K060537enFlow IV Fluid Warmer Part number 980105VS; (510K name: enFlow IV Fluid Warmer Model…Jun 30, 2011
  • K060537Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical…Jul 15, 2010
  • K060537Model 100 enFlow Fluid/Blood Warmer Model Numbers: 980100, 91000103, 91000153, 91000154…Mar 23, 2009