Cleared Traditional

K760167 - BAG

K760167 is the FDA 510(k) clearance for BAG by Dytek Corp.. It is a Class 2 Anesthesiology device (product code BWF) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K760167 · Dytek Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1976
Decision
31d
Days
Class 2
Risk

K760167 is an FDA 510(k) clearance for the BAG, POST OPERATIVE LUNG EXERCIZING BLOW. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Dytek Corp. (Mchenry, US). The FDA issued a Cleared decision on August 6, 1976 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5690 - 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 Dytek Corp. devices

Submission Details

510(k) Number K760167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1976
Decision Date August 06, 1976
Days to Decision 31 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 140d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BWF Spirometer, Therapeutic (incentive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5690
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.