510(k) Report

FDA applicant

Health Care Technologies

Ashland, MA1 decision2019–20192 recalls

FDA records 1 decision for Health Care Technologies (Ashland, MA) in 2019: 1 510(k) clearance. All are in product code KPE (Container, I.V.). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 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 Health Care Technologies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

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

2026 so far, outlined.

Recalls per year

2in 2022

2022: 2
2019high 2 (2022) · low 0 (2019)2026

Class I Class II/III not classified

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

Planning a device like Health Care Technologies’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?

  • KPEContainer, I.V.1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K190328HCT Empty EVA Container PackHealth Care Technologies · 20192 recalls

The one decision as Health Care Technologies →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K190328HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER…Dec 15, 2022Class II
  • K190328HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE.…Dec 15, 2022Class II