Cleared Traditional

K782016 - SPIROCARE 108-B

K782016 is the FDA 510(k) clearance for SPIROCARE 108-B by Marion Laboratories, Inc.. It is a Class 2 Anesthesiology device (product code BWF) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K782016 · Marion Laboratories, Inc. · Anesthesiology device
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Dec 1978
Decision
8d
Days
Class 2
Risk

K782016 is an FDA 510(k) clearance for the SPIROCARE 108-B. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Marion Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 13, 1978 after a review of 8 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 Marion Laboratories, Inc. devices

Submission Details

510(k) Number K782016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1978
Decision Date December 13, 1978
Days to Decision 8 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
132d faster than avg
Panel avg: 140d · This submission: 8d
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.

Regulatory Peers - BWF Spirometer, Therapeutic (incentive)

All 28
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K782016.
MOTIVATOR
K791842 · Puritan Bennett Corp. · Oct 1979
AIR INCENTIVE SPIROMETER
K791819 · Airlife, Inc. · Sep 1979
VOLUREX TM
K791015 · Dhd Medical Products Div. Diemolding Corp. · Jun 1979
CALCULATOR, WITH CHARGER
K781838 · C.R. Bard, Inc. · Nov 1978
RESPIRATORY EXERCISOR, VOLUME PULSE
K781669 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1978
SPIROMETEO & LUNG EXERCISER, 4601
K771532 · Boehringer Laboratories · Aug 1977