510(k) Report

FDA applicant

Respiratory Delivery Systems, Inc.

Lowell, MA2 decisions1990–19920 recalls

FDA records 2 decisions for Respiratory Delivery Systems, Inc. (Lowell, MA) from 1990 to 1992: 2 510(k) clearances. All are in product code CAF (Nebulizer (Direct Patient Interface)). No 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Respiratory Delivery Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Respiratory Delivery Systems, 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.