Cleared Traditional

K781706 - RESPIRATOR/GILL 1/SIMV

K781706 is an FDA 510(k) clearance for RESPIRATOR/GILL 1/SIMV, manufactured by Chemetron Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code CBO cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K781706 · Chemetron Medical Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1979
Decision
104d
Days
Class 2
Risk

K781706 is an FDA 510(k) clearance for the RESPIRATOR/GILL 1/SIMV. Classified as Attachment, Intermittent Mandatory Ventilation (imv) (product code CBO), Class II - Special Controls.

Submitted by Chemetron Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 22, 1979 after a review of 104 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K781706

510(k) Number K781706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1978
Decision Date January 22, 1979
Days to Decision 104 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 140d · This submission: 104d
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 11
Devices cleared under the same product code (CBO) and FDA review panel - the closest regulatory comparables to K781706.
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
INSPIRON I.M.V. SET UP
K760891 · Inspiron Corp. · Dec 1976
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
K781706 · RESPIRATOR/GILL 1/SIMV
Download PDF Chemetron Medical Pro…