Cleared Traditional

K991785 - MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K991785 · Instrumentation Industries, Inc. · Anesthesiology device
Aug 1999
Decision
84d
Days
Class 2
Risk

K991785 is an FDA 510(k) clearance for the MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITH.... Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on August 17, 1999 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5925 - 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.

Submission Details

510(k) Number K991785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1999
Decision Date August 17, 1999
Days to Decision 84 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Regulatory Context
Review time vs. panel average
141d faster than avg
Panel avg: 225d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTL Ventilator, Emergency, Powered (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5925
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.