Cleared Traditional

K020797 - PULMO-MIST COMPRESSOR MODEL # 4323

K020797 is the FDA 510(k) clearance for PULMO-MIST COMPRESSOR MODEL # 4323 by Nidek Medical Products, Inc.. It is a Class 2 Anesthesiology device (product code BTI) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K020797 · Nidek Medical Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
52d
Days
Class 2
Risk

K020797 is an FDA 510(k) clearance for the PULMO-MIST COMPRESSOR MODEL # 4323. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Nidek Medical Products, Inc. (Birmingham, US). The FDA issued a Cleared decision on May 3, 2002 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6250 - 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 Nidek Medical Products, Inc. devices

Submission Details

510(k) Number K020797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2002
Decision Date May 03, 2002
Days to Decision 52 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 140d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code BTI Compressor, Air, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.6250
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 - BTI Compressor, Air, Portable

All 7
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K020797.
AEROMIST LT, MODEL HCS15004
K031686 · Medline Industries, Inc. · Jan 2004
COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E
K023354 · Siemens Elema AB · Sep 2003
SAM ST
K913097 · Ferguson Medical · Dec 1992
NEBULIZER SYSTEM
K922623 · Healthdyne, Inc. · Dec 1992
SIEMENS DRY AIR COMPRESSOR
K871829 · Siemens Elema AB · Jun 1987
BIRD 6500 AIR COMPRESSOR
K864547 · Bird Products Corp. · Jan 1987