Cleared Traditional

K863866 - RESPIRADYNE II(TM)

K863866 is an FDA 510(k) clearance for RESPIRADYNE II(TM), manufactured by Chesebrough-Pond'S U.S.A. Co.. The device is a Class 2 Anesthesiology device with product code BZK cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K863866 · Chesebrough-Pond'S U.S.A. Co. · Anesthesiology device
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Jan 1987
Decision
117d
Days
Class 2
Risk

K863866 is an FDA 510(k) clearance for the RESPIRADYNE II(TM). Classified as Spirometer, Monitoring (w/wo Alarm) (product code BZK), Class II - Special Controls.

Submitted by Chesebrough-Pond'S U.S.A. Co. (Trumbull, US). The FDA issued a Cleared decision on January 28, 1987 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1850 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Chesebrough-Pond'S U.S.A. Co. devices

FDA 510(k) Submission Details - K863866

510(k) Number K863866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1986
Decision Date January 28, 1987
Days to Decision 117 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
23d faster than avg
Panel avg: 140d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZK Device Classification - Class 2, Special Controls

Product Code BZK Spirometer, Monitoring (w/wo Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1850
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 - BZK Spirometer, Monitoring (w/wo Alarm)

All 28
Devices cleared under the same product code (BZK) and FDA review panel - the closest regulatory comparables to K863866.
MONAGHAN RVM, MODEL 761
K884942 · Monaghan Medical Corp. · Jun 1989
MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR
K890724 · Bear Medical Systems, Inc. · Mar 1989
BEAR NVM-1
K872660 · Bear Medical Systems, Inc. · Feb 1988
OHMEDA 5410 VOLUME MONITOR
K862687 · Ohmeda Medical · Sep 1986
OHMEDA 5420 VOLUME MONITOR
K862688 · Ohmeda Medical · Sep 1986
BEAR NICU-1
K853346 · Bear Medical Systems, Inc. · Sep 1985