FDA applicant

Hill-Rom Air-Shields

Hatboro, PA5 decisions2000–20033 recalls

FDA records 5 decisions for Hill-Rom Air-Shields (Hatboro, PA) from 2000 to 2003: 5 510(k) clearances. Most are in product codes FMZ (Incubator, Neonatal) and FPL (Incubator, Neonatal Transport). Its devices cite 5 predicates, 0 of them its own earlier devices. 3 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 Hill-Rom Air-Shields’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hill-Rom Air-Shields since 2007.

Recalls per year

1in 2009

2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Hill-Rom Air-Shields by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hill-Rom Air-Shields’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 “Hill-Rom”

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

Hill-Rom, Inc. 37 Hill Laboratories Co. 17 Hill-Med, Inc. 10 Hill-Rom Services Pte, Ltd. 5 Hill-Rom Manufacturing, Inc. 4 Hill-Rom Holdings, Inc. 1 Hill Engineering 1 Hill, Farrer & Borrill 1 Hill-Rom Services Private Limited 1 Hill Top Research, Inc. 1

Hill-Rom Air-Shields

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?

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Other applicant names beginning “Hill-Rom”