MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR— 510(k) K111570

Name: FDA 510(k) clearance K111570
Creator: U.S. Food and Drug Administration
Published: 2011-09-29

Substantially Equivalent

Thayer Medical Corporation

FDA 510(k) clearance K111570 for MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR, Substantially Equivalent on 2011-09-29. Applicant: Thayer Medical Corporation. Device class: 2.

Clearance details

Applicant: Thayer Medical Corporation
Product code: Code CAF
Device class: Class 2
Regulation: 21 CFR 868.5630
Advisory panel: Anesthesiology
Date received: 2011-06-06
Decision date: 2011-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K111570

K-number listed on FDA's recall record

Z-1146-2017 — Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1543A. The 15 mm Dual Spray MiniSpacer with Counter Incrementing Actuator is a non-sterile, single-use item, intended to dispense aerosolized medication into a breathing circuit or ancillary circuits. MINISPACER adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. The 15 mm device is installed and operated by licensed healthcare practitioners in clinical settings. The design of the actuator component of REF 1543A has been enhanced by the addition of a linear gear designed to increment the dose-counter on some pMDI canisters. REF 1543A provides standard dimension connectors (15 mm outer diameter x 15 mm inner diameter) for connection to the ventilator circuit. The device design incorporates a dual spray nozzle that allows a path for the medication to travel through the stem and directs the medication through the dual orifices into the airstreamClass II·Terminated·Thayer Medical Corporation·20160929

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111570.

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