CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT— 510(k) K861555

Name: FDA 510(k) clearance K861555
Creator: U.S. Food and Drug Administration
Published: 1986-06-05

Substantially Equivalent

Respiratory Care, Inc.

FDA 510(k) clearance K861555 for CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT, Substantially Equivalent on 1986-06-05. Applicant: Respiratory Care, Inc.. Device class: 2.

Clearance details

Applicant: Respiratory Care, Inc.
Product code: Code BZD
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 1986-04-25
Decision date: 1986-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZD

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K253166 — F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)2026-04-29

More clearances from Respiratory Care, Inc.

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K892230 — RCI VIRAL/BACTERIAL FILTER1989-08-28
K884150 — MODIFIED CONCHATHERM III CONTROLLED HEATER1988-11-21
K881625 — CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL1988-06-21
K864147 — AQUAVALVE1986-12-05
K863955 — COLBY LEVEL ALARM1986-11-07

Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.