Cleared Traditional

K760891 - INSPIRON I.M.V. SET UP

K760891 is an FDA 510(k) clearance for INSPIRON I.M.V. SET UP, manufactured by Inspiron Corp.. The device is a Class 2 Anesthesiology device with product code CBO cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K760891 · Inspiron Corp. · Anesthesiology device
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Dec 1976
Decision
44d
Days
Class 2
Risk

K760891 is an FDA 510(k) clearance for the INSPIRON I.M.V. SET UP. Classified as Attachment, Intermittent Mandatory Ventilation (imv) (product code CBO), Class II - Special Controls.

Submitted by Inspiron Corp. (Mchenry, US). The FDA issued a Cleared decision on December 9, 1976 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5955 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Inspiron Corp. devices

FDA 510(k) Submission Details - K760891

510(k) Number K760891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1976
Decision Date December 09, 1976
Days to Decision 44 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 140d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBO Device Classification - Class 2, Special Controls

Product Code CBO Attachment, Intermittent Mandatory Ventilation (imv)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5955
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CBO Attachment, Intermittent Mandatory Ventilation (imv)

All 10
Devices cleared under the same product code (CBO) and FDA review panel - the closest regulatory comparables to K760891.
FALL-SAFE IMV #M-511
K791911 · Mem Medical, Inc. · Oct 1979
IMV FOR MONITORING #M-510
K791912 · Mem Medical, Inc. · Oct 1979
IMV MANIFOLD #M-506
K791913 · Mem Medical, Inc. · Oct 1979
INTERMITTENT MANDATORY VENTILATION
K760680 · B & F Medical Products, Inc. · Sep 1976
VALVE, I.M.V. (U-MID ONE WAY)
K760039 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1976