Cleared Traditional

K800386 - ARGYLE TRU-VOL

K800386 is an FDA 510(k) clearance for ARGYLE TRU-VOL, manufactured by Sherwood Medical Co.. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K800386 · Sherwood Medical Co. · Anesthesiology device
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Feb 1980
Decision
6d
Days
Class 2
Risk

K800386 is an FDA 510(k) clearance for the ARGYLE TRU-VOL. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on February 28, 1980 after a review of 6 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 Sherwood Medical Co. devices

FDA 510(k) Submission Details - K800386

510(k) Number K800386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1980
Decision Date February 28, 1980
Days to Decision 6 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d faster than avg
Panel avg: 140d · This submission: 6d
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 67
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K800386.
MONAGHAN'S TRUE VOLUME EXERCISER
K820606 · Monaghan Medical Corp. · Mar 1982
VOLDYNE VOLUMETRIC INCENTIVE DEEP BR. EX
K801199 · Chesebrough-Pond'S U.S.A. Co. · Jun 1980
BUNN VOLUMAIRE RESPIRATORY EXERCISER
K800546 · The John Bunn Co. · Mar 1980
DISPOSABLE INCENTIVE SPIROMETER
K792598 · Hospitak, Inc. · Jan 1980
MODEL TM2-BEHIND-THE-EAR TINNITUS
K792214 · Starkey Laboratories, Inc. · Nov 1979
AIR INCENTIVE SPIROMETER, W/NEBULIZER
K792217 · Airlife, Inc. · Nov 1979