Cleared Traditional

K781245 - LUNG EXER. BAG, POST-OP, MODIFIED

K781245 is an FDA 510(k) clearance for LUNG EXER. BAG, manufactured by Dytek Corp.. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K781245 · Dytek Corp. · Anesthesiology device
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Sep 1978
Decision
65d
Days
Class 2
Risk

K781245 is an FDA 510(k) clearance for the LUNG EXER. BAG, POST-OP, MODIFIED. 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 September 20, 1978 after a review of 65 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

FDA 510(k) Submission Details - K781245

510(k) Number K781245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1978
Decision Date September 20, 1978
Days to Decision 65 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 140d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BWF Device Classification - Class 2, Special Controls

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.

Regulatory Peers - BWF Spirometer, Therapeutic (incentive)

All 77
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K781245.
CALCULATOR, WITH CHARGER
K781838 · C.R. Bard, Inc. · Nov 1978
EXERCISER, AIR-EZE INCENTIVE
K781833 · Chesebrough-Pond'S U.S.A. Co. · Nov 1978
RESPIRATORY EXERCISOR, VOLUME PULSE
K781669 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1978
FLOW REDUCING ANGULATION STAND
K780265 · Chesebrough-Pond'S U.S.A. Co. · Mar 1978
SPIROMETEO & LUNG EXERCISER, 4601
K771532 · Boehringer Laboratories · Aug 1977
EXERCISOR, RESPIRATORY
K770619 · Cutter Laboratories, Inc. · Apr 1977