UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR— 510(k) K870861

Name: FDA 510(k) clearance K870861
Creator: U.S. Food and Drug Administration
Published: 1988-01-19

Substantially Equivalent

Impact Instrumentation, Inc.

FDA 510(k) clearance K870861 for UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR, Substantially Equivalent on 1988-01-19. Applicant: Impact Instrumentation, Inc.. Device class: 2.

Clearance details

Applicant: Impact Instrumentation, Inc.
Product code: Code CBK
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 1987-03-03
Decision date: 1988-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Caldwell, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CBK

view all

K253647 — Evita (V800); Evita (V600)2026-05-07
K252663 — Inbentus Versatile2026-04-14
K251888 — VPAP Pediatric Face Mask2026-03-12
K232365 — Vivo 45 LS2025-12-19
K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A) +3 more2025-09-10

More clearances from Impact Instrumentation, Inc.

view all

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 →

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