Cleared Traditional

K781838 - CALCULATOR

K781838 is an FDA 510(k) clearance for CALCULATOR, manufactured by C.R. Bard, Inc.. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K781838 · C.R. Bard, Inc. · Anesthesiology device
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Nov 1978
Decision
25d
Days
Class 2
Risk

K781838 is an FDA 510(k) clearance for the CALCULATOR, WITH CHARGER. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 21, 1978 after a review of 25 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K781838

510(k) Number K781838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1978
Decision Date November 21, 1978
Days to Decision 25 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
115d faster than avg
Panel avg: 140d · This submission: 25d
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 39
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K781838.
VOLUREX TM
K791015 · Dhd Medical Products Div. Diemolding Corp. · Jun 1979
SPIROMETER, INCENTIVE CATALOG # 1750
K781831 · Hudson Oxygen Therapy Sales Co. · Dec 1978
SPIROCARE 108-B
K782016 · Marion Laboratories, Inc. · Dec 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