Cleared Traditional

K770633 - BRACKET BE 122-1 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K770633 · Instrumentation Industries, Inc. · Anesthesiology device
May 1977
Decision
49d
Days
Class 2
Risk

K770633 is an FDA 510(k) clearance for the BRACKET BE 122-1. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Instrumentation Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 23, 1977 after a review of 49 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.

Submission Details

510(k) Number K770633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1977
Decision Date May 23, 1977
Days to Decision 49 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Regulatory Context
Review time vs. panel average
176d faster than avg
Panel avg: 225d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 10
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K770633.
eRapid with eTrack System
K251572 · Pari Respiratory Equipment, Inc. · Dec 2025
Mesh Nebulizer (H6)
K251659 · Qingdao Future Medical Technology Co., Ltd. · Nov 2025
Portable mesh nebulizer (JM821)
K244035 · Shenzhen Jermei Medical Device Technology Co., Ltd. · Sep 2025
Compressor Nebulizer (NB-1100)
K243468 · Joytech Healthcare Co. , Ltd. · Jul 2025
HeroTracker Sense
K250022 · Voluntis · Jun 2025
AdheResp Smart Breath-actuated Mesh Nebulizer
K250583 · Hcmed Innovations Co., Ltd. · Jun 2025