BLEASE700/900 SERIES VENTILATORS— 510(k) K112729

Name: FDA 510(k) clearance K112729
Creator: U.S. Food and Drug Administration
Published: 2012-06-11

Substantially Equivalent

Spacelabs Healthcare

FDA 510(k) clearance K112729 for BLEASE700/900 SERIES VENTILATORS, Substantially Equivalent on 2012-06-11. Applicant: Spacelabs Healthcare. Device class: 2.

Clearance details

Applicant: Spacelabs Healthcare
Product code: Code CBK
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 2011-09-20
Decision date: 2012-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nederland, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

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 K112729

K-number listed on FDA's recall record

Z-1458-2015 — Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators. Designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia.Class II·Terminated·Del Mar Reynolds Medical, Ltd.·20150305

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112729.

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