FDA applicant

Respiratory Motion, Inc.

Waltham, MA5 decisions2012–20190 recalls

FDA records 5 decisions for Respiratory Motion, Inc. (Waltham, MA) from 2012 to 2019: 5 510(k) clearances. All are in product code BZK (Spirometer, Monitoring (W/Wo Alarm)). Its devices cite 6 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Respiratory Motion”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Respiratory Motion, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2012high 1 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Respiratory Motion, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Respiratory Motion, 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 “Respiratory”

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

Respiratory Support Products, Inc. 27 Respiratory Care, Inc. 26 Respiratory Delivery Systems, Inc. 2 Respiratory Technologies, Incorporated 1 Respiratory Marketing, Inc. 1 Respiratory Therapy 1

Respiratory Motion, 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?

Other applicant names beginning “Respiratory”