Cleared Traditional

K923690 - MINI HEART

K923690 is an FDA 510(k) clearance for MINI HEART, manufactured by B&B Medical Technologies, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K923690 · B&B Medical Technologies, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
88d
Days
Class 2
Risk

K923690 is an FDA 510(k) clearance for the MINI HEART. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by B&B Medical Technologies, Inc. (Rancho Cordova, US). The FDA issued a Cleared decision on October 20, 1992 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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 B&B Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K923690

510(k) Number K923690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1992
Decision Date October 20, 1992
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 140d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 223
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K923690.
COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800)
K921809 · Puritan Bennett Corp. · Dec 1992
SAM LS
K913095 · Ferguson Medical · Dec 1992
SAM SC
K913096 · Ferguson Medical · Dec 1992
HEART NEBULIZER
K923596 · Vortran Medical Technology 1, Inc. · Oct 1992
NE-U07
K922923 · Omron Healthcare, Inc. · Sep 1992
NE-U04/NE U04F
K923024 · Omron Healthcare, Inc. · Sep 1992