510(k) Report

FDA applicant

Borning Corp.

Spokane, WA1 decision1985–19851 recall

FDA records 1 decision for Borning Corp. (Spokane, WA) in 1985: 1 510(k) clearance. All are in product code FMT (Warmer, Infant Radiant). 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 Borning Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Borning Corp. since 2007.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • FMTWarmer, Infant Radiant1decision

What has FDA decided for it lately?

  • K850069Borning Neonatal Resuscitatoin CenterBorning Corp. · 19851 recall

The one decision as Borning Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K042607Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000…Jul 17, 2009