Cleared Traditional

K863538 - RESPICENTRAL(TM)

K863538 is an FDA 510(k) clearance for RESPICENTRAL(TM), manufactured by Dickstein, Shapiro & Morin. The device is a Class 2 Anesthesiology device with product code BZK cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K863538 · Dickstein, Shapiro & Morin · Anesthesiology device
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Sep 1986
Decision
13d
Days
Class 2
Risk

K863538 is an FDA 510(k) clearance for the RESPICENTRAL(TM). Classified as Spirometer, Monitoring (w/wo Alarm) (product code BZK), Class II - Special Controls.

Submitted by Dickstein, Shapiro & Morin (Washington, US). The FDA issued a Cleared decision on September 24, 1986 after a review of 13 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K863538

510(k) Number K863538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1986
Decision Date September 24, 1986
Days to Decision 13 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 140d · This submission: 13d
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 41
Devices cleared under the same product code (BZK) and FDA review panel - the closest regulatory comparables to K863538.
MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR
K890724 · Bear Medical Systems, Inc. · Mar 1989
BEAR NVM-1
K872660 · Bear Medical Systems, Inc. · Feb 1988
RESPIRADYNE II(TM)
K863866 · Chesebrough-Pond'S U.S.A. Co. · Jan 1987
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
K863538 · RESPICENTRAL(TM)
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