Cleared Traditional

K853346 - BEAR NICU-1

K853346 is an FDA 510(k) clearance for BEAR NICU-1, manufactured by Bear Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code BZK cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K853346 · Bear Medical Systems, Inc. · Anesthesiology device
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Sep 1985
Decision
30d
Days
Class 2
Risk

K853346 is an FDA 510(k) clearance for the BEAR NICU-1. Classified as Spirometer, Monitoring (w/wo Alarm) (product code BZK), Class II - Special Controls.

Submitted by Bear Medical Systems, Inc. (Riverside, US). The FDA issued a Cleared decision on September 11, 1985 after a review of 30 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.

View all Bear Medical Systems, Inc. devices

FDA 510(k) Submission Details - K853346

510(k) Number K853346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date September 11, 1985
Days to Decision 30 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
110d faster than avg
Panel avg: 140d · This submission: 30d
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 K853346.
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
OHMEDA RM311 RESPIROMETER
K843799 · Ohmeda Medical · Oct 1984
OHMEDA RM121 RESPIROMETER
K843800 · Ohmeda Medical · Oct 1984
MEDISHIELD PVM RESPIROMETER
K840453 · Ohio Medical Products · Mar 1984