Cleared Traditional

K833265 - RESPIRATORY FLOW MODULE

K833265 is an FDA 510(k) clearance for RESPIRATORY FLOW MODULE, manufactured by Thoratec Laboratories Corp.. The device is a Class 2 Anesthesiology device with product code JAX cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K833265 · Thoratec Laboratories Corp. · Anesthesiology device
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Nov 1983
Decision
68d
Days
Class 2
Risk

K833265 is an FDA 510(k) clearance for the RESPIRATORY FLOW MODULE. Classified as Pneumotachometer (product code JAX), Class II - Special Controls.

Submitted by Thoratec Laboratories Corp. (Mchenry, US). The FDA issued a Cleared decision on November 28, 1983 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2550 - 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 Thoratec Laboratories Corp. devices

FDA 510(k) Submission Details - K833265

510(k) Number K833265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1983
Decision Date November 28, 1983
Days to Decision 68 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 140d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAX Device Classification - Class 2, Special Controls

Product Code JAX Pneumotachometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2550
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.